Title 21—Food and Drugs--Volume 1
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.23   Acepromazine.
(a) Specifications. Each tablet contains 10 or 25 milligrams (mg) acepromazine maleate.
(b) Sponsors. See Nos. 000010 and 086117 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. 0.25 to 1.0 mg per pound (/lb) body weight orally.
(ii) Indications for use. As an aid in tranquilization and as a preanesthetic agent.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. 0.5 to 1.0 mg/lb body weight orally.
(ii) Indications for use. As a tranquilizer.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.28   Acetazolamide.
(a) Specifications. A powder containing acetazolamide sodium, USP equivalent to 25 percent acetazolamide activity.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally at a dosage of 5 to 15 milligrams per pound of body weight daily.
(2) Indications for use. As an aid in the treatment of mild congestive heart failure and for rapid reduction of intraocular pressure.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.35   Afoxolaner, moxidectin, and pyrantel.
(a) Specifications. Each chewable tablet contains:
(1) 9.375 milligrams (mg) afoxolaner, 45 micrograms (mcg) moxidectin, and 18.75 mg pyrantel (as pamoate salt);
(2) 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel (as pamoate salt);
(3) 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel (as pamoate salt);
(4) 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel (as pamoate salt); or
(5) 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel (as pamoate salt).
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel. For heartworm disease prevention, give once monthly for at least 6 months after last exposure to mosquitoes.
(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala ) and roundworm ( Toxocara canis and Toxascaris leonina ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), and Haemaphysalis longicornis (longhorned tick) infestations for 1 month in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.38   Albendazole oral dosage forms.
§ 520.38a   Albendazole suspension.
(a) Specifications. Each milliliter of suspension contains 45.5 milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.
(b) Sponsor. See No. 054771 in § 510.600 of this chapter.
(c) Related tolerances. See § 556.34 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use —(1) Cattle. Administer 11.36 percent suspension:
(i) Amount. 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as a single oral dose using dosing gun or dosing syringe.
(ii) Indications for use. For removal and control of adult liver flukes ( Fasciola hepatica ); heads and segments of tapeworms ( Moniezia benedeni and M. expansa ); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae ( Ostertagia ostertagi ), barberpole worm ( Haemonchus contortus and H. placei ), small stomach worm ( Trichostrongylus axei )); adult and 4th stage larvae of intestinal worms (thread-necked intestinal worm ( Nematodirus spathiger and N. helvetianus ), small intestinal worm ( Cooperia punctata and C. oncophora )); adult stages of intestinal worms (hookworm ( Bunostomum phlebotomum ), bankrupt worm ( Trichostrongylus colubriformis ), nodular worm ( Oesophagostomum radiatum )); adult and 4th stage larvae of lungworms ( Dictyocaulus viviparus ).
(iii) Limitations. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls.
(2) Sheep. Administer 4.45 or 11.36 percent suspension:
(i) Amount. 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose using dosing gun or dosing syringe.
(ii) Indications for use. For removal and control of adult liver flukes ( Fasciola hepatica and Fascioloides magna ); heads and segments of common tapeworms ( Moniezia expansa ) and fringed tapeworm ( Thysanosoma actinioides ); adult and fourth stage larvae of stomach worms (brown stomach worm ( Ostertagia circumcinta and Marshallagia marshalli ), barberpole worm ( Haemonchus contortus ), small stomach worm ( Trichostrongylus axei )); adult and fourth stage larvae of intestinal worms (thread-necked intestinal worm ( Nematodirus spathiger and N. filicollis ), Cooper's worm ( Cooperia oncophora ), bankrupt worm ( Trichostrongylus colubriformis ), nodular worm ( Oesophagostomum columbianum ), and large-mouth bowel worm ( Chabertia ovina )); adult and larval stages of lungworms ( Dictyocaulus filaria ).
(iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to ewes during first 30 days of pregnancy or for 30 days after removal of rams.
(3) Goats. Administer 11.36 percent suspension:
(i) Amount. 4.54 mg/lb body weight (10 mg/kg) as a single oral dose using dosing gun or dosing syringe.
(ii) Indications for use. For the treatment of adult liver flukes ( Fasciola hepatica ) in nonlactating goats.
(iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to does during the first 30 days of pregnancy or for 30 days after removal of bucks.
§ 520.38b   Albendazole paste.
(a) Specifications. The product contains 30 percent albendazole.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.34 of this chapter.
(d) Conditions of use in cattle —(1) Amount. Equivalent to 4.54 milligrams per 1 pound of body weight (10 milligrams per kilogram).
(2) Indications for use. For removal and control of the following internal parasites of cattle: adult liver flukes ( Fasciola hepatica ); heads and segments of tapeworms ( Moniezia benedeni, M. expansa ); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae ( Ostertagia ostertagi ); barberpole worm ( Haemonchus contortus, H. placei ); small stomach worm ( Trichostrongylus axei )); adult and 4th stages larvae of intestinal worms (thread-necked intestinal worm ( Nematodirus spathiger, N. helvetianus ); small intestinal worm ( Cooperia punctata and C. oncophora )); adult stages of intestinal worms (hookworm ( Bunostomum phlebotmum ); bankrupt worm ( Trichostrongylus colubriformis ), nodular worm ( Oesophagostomum radiatum )); adult and 4th stage larvae of lungworms ( Dictyocaulus viviparus ).
(3) Limitations. Administer as a single oral dose. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age. Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.43   Afoxolaner.
(a) Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer orally once a month at a minimum dosage of 1.14 mg/pound (2.5 mg/kilogram).
(2) Indications for use. Kills adult fleas and for the treatment and prevention of flea infestations ( Ctenocephalides felis ); and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.48   Altrenogest.
(a) Specifications. Each milliliter (mL) of solution contains 2.2 milligrams (mg) altrenogest.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter:
(1) Nos. 000061 and 051072 for use as in paragraph (d) of this section.
(2) No. 061133 for use as in paragraph (d)(1) of this section.
(3) No. 013744 for use as in paragraph (d)(2) of this section.
(c) Tolerances. See § 556.36 of this chapter.
(d) Conditions of use—(1) Horses —(i) Amount. 1.0 mL per 110 pounds body weight (0.044 mg/kg) daily for 15 consecutive days.
(ii) Indications for use. For suppression of estrus in mares.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine —(i) Amount. Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days by top-dressing on a portion of each gilt's daily feed.
(ii) Indications for use. For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle.
(iii) Limitations. Do not use in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis). Gilts must not be slaughtered for human consumption for 21 days after the last treatment.
§ 520.62   Aminopentamide.
(a) Specifications. Each tablet contains 0.2 milligram (mg) aminopentamide hydrogen sulphate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer orally every 8 to 12 hours as follows: For animals weighing up to 10 pounds (lbs): 0.1 mg; for animals weighing 11 to 20 lbs: 0.2 mg; for animals weighing 21 to 50 lbs: 0.3 mg; for animals weighing 51 to 100 lbs: 0.4 mg; for animal weighing over 100 lbs: 0.5 mg. Dosage may be gradually increased up to a maximum of five times the suggested dosage. Oral administration of tablets may be preceded by subcutaneous or intramuscular use of the injectable form of the drug.
(2) Indications for use. For the treatment of vomiting and/or diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.82   Aminopropazine oral dosage forms.
§ 520.82a   Aminopropazine.
(a) Specifications. Each tablet contains aminopropazine fumarate equivalent to 25 percent aminopropazine base.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer orally at a dosage of 1 to 2 milligrams per pound of body weight, repeated every 12 hours as indicated.
(2) Indications for use. For reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.82b   Aminopropazine and neomycin.
(a) Specifications. Each tablet contains aminopropazine fumarate equivalent to 25 percent aminopropazine base and neomycin sulfate equivalent to 50 milligrams (mg) of neomycin base.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally at a dosage of 1 to 2 mg per pound of body weight, repeated every 12 hours as indicated.
(2) Indications for use. For control of bacterial diarrhea caused by organisms susceptible to neomycin and to reduce smooth muscle contractions.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.88   Amoxicillin oral dosage forms.
§ 520.88a   Amoxicillin trihydrate film-coated tablets.
(a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days.
(ii) Indications for use. Treatment of infections of the respiratory tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), gastrointestinal tract (bacterial gastroenteritis), and soft tissues (abscesses, lacerations, wounds), caused by susceptible strains of Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus mirabilis, and bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days.
(ii) Indications for use. Treatment of infections caused by susceptible organisms as follows: upper respiratory tract due to S. aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract due to E. coli; and skin and soft tissue (abscesses, lacerations, and wounds) due to S. aureus, Streptococcus spp., E. coli, and Pasteurella multocida.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.88b   Amoxicillin trihydrate for oral suspension.
(a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(1) Conditions of use —(i) Dogs —(A) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days.
(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) caused by Staphylococcus aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; genitourinary tract (cystitis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract (bacterial gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis.
(C) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(ii) Cats —(A) Amount. Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days.
(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: upper respiratory tract due to Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida.
(C) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
(c) Sponsors. See Nos. 000856 and 051311 in § 510.600(c) of this chapter.
(1) Conditions of use. Dogs —(i) Amount. Administer orally 5 mg/lb of body weight, twice a day for 5 to 7 days.
(ii) Indications for use. Treatment of bacterial dermatitis due to S. aureus, Streptococcus spp., Staphylococcus spp., and E. coli, and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis and Staphylococcus spp.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 520.88c   Amoxicillin trihydrate oral suspension.
(a) Specifications. Each 0.8-milliliter dose contains amoxicillin trihydrate equivalent to 40 milligrams (mg) amoxicillin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.38 of this chapter.
(d) Conditions of use in swine —(1) Amount. Administer 40 mg orally twice a day using a dosing pump. Treat animals for 48 hours after all symptoms have subsided but not beyond 5 days.
(2) Indications for use. Treatment of baby pigs under 10 pounds for porcine colibacillosis caused by Escherichia coli susceptible to amoxicillin.
(3) Limitations. Do not slaughter during treatment or for 15 days after latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.88d   Amoxicillin trihydrate soluble powder.
(a) Specifications. Each gram of powder contains amoxicillin trihydrate equivalent to 115.4 milligrams (mg) amoxicillin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.38 of this chapter.
(d) Conditions of use in preruminating calves including veal calves —(1) Amount. Administer 400 mg per 100 pounds of body weight twice daily by drench or in milk. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days.
(2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves.
(3) Limitations. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian
§ 520.88e   Amoxicillin trihydrate boluses.
(a) Specifications. Each bolus contains amoxicillin trihydrate equivalent to 400 milligrams (mg) amoxicillin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.38 of this chapter.
(d) Conditions of use in cattle —(1) Amount. Administer 400 mg per 100 pounds of body weight twice daily. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days.
(2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves.
(3) Limitations. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.88f   Amoxicillin trihydrate tablets.
(a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 200, or 400 milligrams (mg) amoxicillin.
(b) Sponsors. See Nos. 051311 and 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 5 mg per pound of body weight twice daily for 5 to 7 days or 48 hours after all symptoms have subsided.
(2) Indications for use. For treatment of bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and Escherichia coli; and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Enterococcus faecalis, E. coli, Proteus mirabilis, and Staphylococcus spp.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.88g   Amoxicillin and clavulanate potassium tablets.
(a) Specifications. Each tablet or chewable tablet contains amoxicillin and clavulanate potassium equivalent to 50 milligrams (mg) amoxicillin and 12.5 mg clavulanic acid, 100 mg amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter:
(1) No. 054771 for use of tablets and chewable tablets as in paragraph (c) of this section.
(2) Nos. 017033 and 069043 for use of tablets as in paragraph (c) of this section.
(3) No. 013744 for use of chewable tablets as in paragraph (c) of this section.
(c) Conditions of use —(1) Dogs —(i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic acid) per pound of body weight twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days.
(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and E. coli. Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. 62.5 milligrams (50 milligrams amoxicillin and 12.5 milligrams clavulanic acid) twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days.
(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.88h   Amoxicillin trihydrate and clavulanate potassium for oral suspension.
(a) Specifications. When constituted, each milliliter (mL) of suspension contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg clavulanic acid.
(b) Sponsors. See Nos. 017033, 054771, and 069043 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. 6.25 mg/lb (1 mL/10 lb of body weight) twice a day. Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5 to 7 days or for 48 hours after all signs have subsided. If no response is seen after 5 days of treatment, therapy should be discontinued and the case reevaluated. Deep pyoderma may require treatment for 21 days; the maximum duration of treatment should not exceed 30 days.
(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment of periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. 62.5 mg (1 mL) twice daily. Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5 to 7 days or 48 hours after all symptoms have subsided, not to exceed 30 days. If no response is seen after 3 days of treatment, therapy should be discontinued and the case reevaluated. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days.
(ii) Indications for use. Treatment of skin and soft tissue infections, such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., Escherichia coli, Pasteurella multocida, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.90   Ampicillin oral dosage forms.
§ 520.90a   Ampicillin tablets.
(a) Specifications. Each tablet contains ampicillin trihydrate equivalent to 50 or 100 milligrams of ampicillin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 5 milligrams per pound of body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be continued 36 to 48 hours after all symptoms have subsided. If no improvement is seen within 5 days, stop treatment, reevaluate diagnosis, and change therapy.
(2) Indications for use. Oral treatment of infections caused by susceptible organisms as follows: Upper respiratory infections, tonsillitis, and bronchitis due to Streptococcus spp., Staphylococcus spp., Escherichia coli, Proteus mirabilis, and Pasteurella spp., urinary tract infections (cystitis) due to Streptococcus spp., Staphylococcus spp., E., coli, P. mirabilis, and Enterococcus spp.; gastrointestinal infections due to Staphylococcus spp., Streptococcus spp., Enterococcus spp., and E. coli. ; infections associated with abscesses, lacerations, and wounds caused by Staphylococcus spp., and Streptococcus spp.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.90b   Ampicillin capsules.
(a) Specifications. Each capsule contains ampicillin trihydrate equivalent to 125, 250, or 500 milligrams of ampicillin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. 5 to 10 milligrams per pound of body weight two or three times daily. In severe or acute conditions, 10 milligrams per pound of body weight, three times daily. Administer 1 to 2 hours prior to feeding.
(ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory tract infections (tracheobronchitis and tonsillitis); urinary tract infections (cystitis); bacterial gastroenteritis; generalized infections (septicemia) associated with abscesses, lacerations, and wounds; and bacterial dermatitis.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. 10 to 30 milligrams per pound of body weight or three times daily. Administer 1 to 2 hours prior to feeding.
(ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory tract infections (bacterial pneumonia); urinary tract infections (cystitis); and generalized infections (septicemia) associated with abscesses, lacerations, and wounds.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.90c   Ampicillin boluses.
(a) Specifications. Each bolus contains ampicillin trihydrate equivalent to 400 milligrams of ampicillin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.40 of this chapter.
(d) Conditions of use in nonruminating calves —(1) Amount. 5 milligrams per pound of body weight twice daily not to exceed 4 days.
(2) Indications for use. Oral treatment of bacterial enteritis (colibacillosis) caused by E. coli.
(3) Limitations. Treated calves must not be slaughtered for food during treatment and for 7 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.100   Amprolium.
(a) Specifications. (1) Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution).
(2) Each gram of powder contains 200 mg amprolium (20 percent).
(b) Sponsors. See sponsors in 510.600(c) of this chapter.
(1) Nos. 016592 and 061133 for use of products described in paragraph (a) of this section as in paragraph (d) of this section.
(2) Nos. 051072 and 066104 for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section.
(c) Related tolerances. See § 556.50 of this chapter.
(d) Conditions of use —(1) Growing chickens, turkeys, and laying hens. It is used in drinking water as follows:
(i) Amount. Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level); continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.
(ii) Indications for use. For the treatment of coccidiosis.
(iii) Limitations. Use as the sole source of amprolium.
(2) Calves. Administer concentrate solution or soluble powder as a drench or in drinking water as follows:
(i) Indications for use and amounts —(A) As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii , administer 5 mg per kilogram (mg/kg) body weight for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard.
(B) As an aid in the treatment of coccidiosis caused by E. bovis and E. zurnii , administer 10 mg/kg body weight for 5 days.
(ii) Limitations. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Use as the sole source of amprolium.
§ 520.110   Apramycin sulfate soluble powder.
(a) Specifications. A water soluble powder used to make a medicated drinking water containing apramycin sulfate equivalent to 0.375 gram of apramycin activity per gallon of drinking water.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.52 of this chapter.
(d) Conditions of use in swine —(1) Amount. Administer in drinking water at the rate of 12.5 milligrams of apramycin per kilogram (5.7 milligrams per pound) of body weight per day for 7 days.
(2) Indications for use. For the control of porcine colibacillosis (weanling pig scours) caused by strains of Escherichia coli sensitive to apramycin.
(3) Limitations. Do not slaughter treated swine for 28 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.154   Bacitracin oral dosage forms.
§ 520.154a   Bacitracin methylenedisalicylate.
(a) Specifications. Each pound of soluble powder contains the equivalent of 50 grams of bacitracin activity for use as in paragraph (d)(1) or (d)(2) of this section, or the equivalent of 200 grams of bacitracin activity for use as in paragraph (d) of this section.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.70 of this chapter.
(d) Conditions of use —(1) Broiler and replacement chickens —(i) Amount. 100 mg per gal in drinking water.
(A) Indications for use. Aid in the prevention of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin methylenedisalicylate.
(B) Limitations. Prepare a fresh solution daily. Use as the sole source of drinking water.
(ii) Amount. 200 to 400 mg per gal in drinking water. Administer continuously 5 to 7 days or as long as clinical signs persist, then reduce to prevention levels (100 mg/gal).
(A) Indications for use. Treatment of necrotic enteritis caused by C. perfringens susceptible to bacitracin methylenedisalicylate.
(B) Limitations. Prepare a fresh solution daily. Use as the sole source of drinking water.
(2) Growing turkeys —(i) Amount. 400 milligrams (mg) per gallon (gal) in drinking water.
(ii) Indications for use. Aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate.
(iii) Limitations. Prepare a fresh solution daily. Use as the sole source of drinking water.
(3) Swine —(i) Amount. 1 gram per gallon in drinking water.
(ii) Indications for use. Treatment of swine dysentery associated with Brachyspira hyodysenteriae. Administer continuously for 7 days or until signs of dysentery disappear.
(iii) Limitations. Prepare a fresh solution daily. Use as the sole source of drinking water. Treatment not to exceed 14 days. Not to be given to swine that weigh more than 250 pounds.
(4) Growing quail —(i) Amount. 400 mg per gal in drinking water.
(ii) Indications for use. For prevention of ulcerative enteritis due to Clostridium colinum susceptible to bacitracin methylenedisalicylate.
(iii) Limitations. Prepare fresh solution daily. Use as sole source of drinking water.
§ 520.154b   Bacitracin methylenedisalicylate and streptomycin sulfate powder.
(a) Specifications. Each gram of powder contains 200 units bacitracin methylenedisalicylate and streptomycin sulfate equivalent to 20 milligrams of streptomycin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 1 level teaspoonful per 10 pounds of body weight three times daily, mixed in a small quantity of liquid or feed.
(2) Indications for use. For the treatment of bacterial enteritis caused by pathogens susceptible to bacitracin and streptomycin such as Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus spp., and for the symptomatic treatment of associated diarrhea.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.154c   Bacitracin zinc soluble powder.
(a) Specifications. Each pound contains the equivalent of not less than 5 grams of bacitracin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.70 of this chapter.
(d) Conditions of use —(1) Broiler chickens —(i) Amount. 100 milligrams per gallon in drinking water.
(A) Indications for use. Prevention of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin zinc.
(B) Limitations. Prepare a fresh solution daily.
(ii) Amount. 200 to 400 milligrams per gallon in drinking water.
(A) Indications for use. Control of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin zinc.
(B) Limitations. Prepare a fresh solution daily.
(2) Growing quail —(i) Amount. 500 milligrams per gallon in drinking water for 5 days followed by 165 milligrams per gallon in drinking water for 10 days.
(ii) Indications for use. Control of ulcerative enteritis caused by Clostridium spp. Susceptible to bacitracin zinc.
(iii) Limitations. Prepare a fresh solution daily.
§ 520.170   Bexagliflozin.
(a) Specifications. Each tablet contains 15 milligrams bexagliflozin.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer one tablet by mouth to cats 6.6 lb (3.0 kg) or greater once daily, at approximately the same time each day, with or without food, and regardless of blood glucose level.
(2) Indications for use. To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.222   Bunamidine hydrochloride.
(a) Chemical name. N,N -Dibutyl-4-(hexyloxy)-1-naphthamidine hydrochloride.
(b) Specifications. The drug is an oral tablet containing 100, 200, or 400 milligrams of bunamidine hydrochloride.
(c) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(d) Conditions of use. (1) The drug is intended for oral administration to dogs for the treatment of the tapeworms Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus, and to cats for the treatment of the tapeworms Dipylidium caninum and Taenia taeniaeformis.
(2) It is administered to cats and dogs at the rate of 25 to 50 milligrams per kilogram of body weight. The drug should be given on an empty stomach and food should not be given for 3 hours following treatment.
(3) Tablets should not be crushed, mixed with food, or dissolved in liquid. Repeat treatments should not be given within 14 days. The drug should not be given to male dogs within 28 days prior to their use for breeding. Do not administer to dogs or cats having known heart conditions.
(4) For use only by or on the order of a licensed veterinarian.
§ 520.246   Butorphanol tablets.
(a) Specifications. Each tablet contains butorphanol tartrate equivalent to 1, 5, or 10 milligrams (mg) butorphanol base.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 0.25 mg butorphanol base per pound of body weight. Repeat at intervals of 6 to 12 hours as required. Treatment should not normally be required for longer than 7 days.
(2) Indications for use. For the relief of chronic nonproductive cough associated with tracheobronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.260n-Butyl chloride.
(a) Specifications. Each capsule contains 221, 442, 884, or 1,768 milligrams (mg); or 4.42 grams of n -butyl chloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter:
(1) No. 023851 for capsules containing 221, 442, 884, or 1,768 mg, or 4.42 grams (g); and
(2) No. 054771 for capsules containing 221 mg.
(c) Conditions of use in dogs —(1) Amount. Administer capsules orally based on body weight as follows:
(i) Capsules containing 221 mg: Under 5 pounds, 1 capsule per 1 1/4 pounds of body weight.
(ii) Capsules containing 442 mg: Under 5 pounds, 1 capsule per 2 1/2 pounds of body weight.
(iii) Capsules containing 884 mg:
(A) Under 5 pounds, 1 capsule;
(B) 5 to 10 pounds, 2 capsules;
(C) 10 to 20 pounds, 3 capsules;
(D) 20 to 40 pounds, 4 capsules;
(E) Over 40 pounds, 5 capsules.
(iv) Capsules containing 1,768 mg: Dogs weighing 5 to 10 pounds, 1 capsule.
(v) Capsules containing 4.42 g: Dogs weighing 40 pounds or over, 1 capsule.
(2) Indications for use. For the removal of ascarids ( Toxocara canis and Toxascaris leonina ) and hookworms ( Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala ) from dogs.
(3) Limitations. Dogs should not be fed for 18 to 24 hours before being given the drug. Administration of the drug should be followed in 1/2 to 1 hour with a mild cathartic. Normal feeding may be resumed 4 to 8 hours after treatment. Animals subject to reinfection may be retreated in 2 weeks. A veterinarian should be consulted before using in severely debilitated dogs.
§ 520.292   Capromorelin.
(a) Specifications. Each milliliter of solution contains:
(1) 30 milligrams (mg) capromorelin; or
(2) 20 mg capromorelin.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs. Use product described in paragraph (a)(1) of this section as follows:
(i) Amount. Administer 3 mg/kg once daily by mouth.
(ii) Indications for use. For appetite stimulation in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats. Use product described in paragraph (a)(2) of this section as follows:
(i) Amount. Administer 2 mg/kg once daily by mouth.
(ii) Indications for use. For management of weight loss in cats with chronic kidney disease.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.301   Caramiphen ethanedisulfonate and ammonium chloride tablets.
(a) Specifications. Each tablet contains 10 milligrams of 5st caramiphen ethanedisulfonate and 80 milligrams of ammonium chloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. One tablet per 15 to 30 pounds of body weight every 4 to 6 hours.
(2) Indications for use. For relief of cough.
§ 520.302   Carnidazole tablets.
(a) Specifications. Each tablet contains 10 milligrams of carnidazole.
(b) Sponsor. See 053923 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons: 1/2 tablet (5 milligrams).
(2) Indications for use. For treating trichomoniasis (canker) in ornamental and homing pigeons.
(3) Limitations. Not for use in pigeons intended for human food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism or when severely ill birds do not respond to treatment.
§ 520.304   Carprofen.
(a) Specifications. (1) Each caplet contains 25, 75, or 100 milligrams (mg) carprofen.
(2) Each chewable tablet contains 25, 75, or 100 mg carprofen.
(3) Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg carprofen.
(4) Each flavored tablet contains 25, 75, or 100 mg carprofen.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.
(1) Nos. 017033, 054771, 055529, and 082983 for use of products described in paragraphs (a)(1) and (a)(2) of this section as in paragraph (c) of this section.
(2) Nos. 058198, 086101 and 086117 for use of product described in paragraph (a)(2) as in paragraph (c) of this section.
(3) No. 069043 for use of product described in paragraph (a)(3) of this section as in paragraph (c) of this section.
(4) No. 086101 for use of product described in paragraphs (a)(1), (a)(2), and (a)(4) of this section as in paragraph (c) of this section.
(c) Conditions of use in dogs —(1) Amount. 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure.
(2) Indications for use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
(3) Limitations. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.314   Cefadroxil.
(a) Specifications. (1) Each tablet contains 50, 100, or 200 milligrams (mg) or 1 gram of cefadroxil.
(2) Each milliliter of suspension constituted from powder contains 50 mg of cefadroxil.
(b) Sponsor. See No. 042791 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount —(i) Dogs. Administer 10 mg per pound (/lb) body weight twice daily orally.
(ii) Cats. Administer 10 mg/lb body weight once daily orally.
(2) Indications for use —(i) Dogs. For the treatment of skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections, and abscesses due to susceptible strains of Staphylococcus aureus. For the treatment of genitourinary tract infections (cystitis) due to susceptible strains of Escherichia coli , Proteus mirabilis , and S. aureus.
(ii) Cats. For the treatment of skin and soft tissue infections including abscesses, wound infections, cellulitis, and dermatitis caused by susceptible strains of Pasteurella multocida , S. aureus , Staphylococcus epidermidis , and Streptococcus spp.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.370   Cefpodoxime tablets.
(a) Specifications. (1) Each tablet contains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime.
(2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 or 200 mg cefpodoxime.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as follows:
(1) No. 017033 for use of product in paragraph (a)(1) of this section as in paragraph (c) of this section.
(2) No. 054771 for use of products in paragraph (a) of this section as in paragraph (c) of this section.
(c) Conditions of use in dogs —(1) Amount. 5 to 10 mg per kilogram (2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.
(2) Indications for use. For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius , S. aureus , Streptococcus canis (group G, beta-hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.376   Cephalexin.
(a) Specifications. Each chewable tablet contains 75, 150, 300, or 600 milligrams (mg) cephalexin.
(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer 22 mg per kilogram of body weight twice daily for 28 days.
(ii) Indications for use. For the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 520.390   Chloramphenicol oral dosage forms.
§ 520.390a   Chloramphenicol tablets.
(a) Specifications. Each tablet contains 50, 100, 250, or 500 milligrams (mg); 1 or 2.5 grams (g) of chloramphenicol.
(b) Sponsors. See § 510.600(c) of this chapter:
(1) For use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section:
(i) No. 069043 for 100-, 250-, and 500-mg; and 1- and 2.5-g tablets;
(ii) No. 054771 for 100-, 250-, and 500-mg tablets;
(2) For use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this section:
(i) No. 061133 for 50-, 100-, 250-, and 500-mg; and 1-g tablets;
(ii) [Reserved]
(c) Conditions of use in dogs —(1) Amount. Administer 25 mg per pound of body weight by mouth every 6 hours.
(2) Indications for use —(i) For the treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.
(ii) For the treatment of bacterial gastroenteritis associated with bacterial diarrhea, bacterial pulmonary infections, and bacterial infections of the urinary tract caused by susceptible organisms.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.
§ 520.390b   Chloramphenicol capsules.
(a) Specifications. Each capsule contains 50, 100, 250, or 500 milligrams (mg) chloramphenicol.
(b) Sponsors. See Nos. 050057 and 054771 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(c) Special considerations. Federal law prohibits the extralabel use of this product in food-producing animals.
(d) Conditions of use in dogs —(1) Amount. 25 mg per pound of body weight every 6 hours.
(2) Indications for use. For treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.390c   Chloramphenicol palmitate oral suspension.
(a) Specifications. Each milliliter contains chloramphenicol palmitate equivalent to 30 milligrams of chloramphenicol.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use. Dogs —(1) Amount. 25 milligrams per pound of body weight every 6 hours. If no response is obtained in 3 to 5 days, discontinue use and reevaluate diagnosis.
(2) Indications for use. Treatment of bacterial pulmonary infections, infections of the urinary tract, enteritis, and infections associated with canine distemper that are caused by organisms susceptible to chloramphenicol.
(3) Limitations. Not for use in animals that are raised for food production. Must not be used in meat-, egg-, or milk-producing animals. The length of time that residues persist in milk or tissues has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.434   Chlorphenesin carbamate tablets.
(a) Specifications. Each tablet contains 400 milligrams of chlorphenesin carbamate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 50 milligrams per pound of body weight on first day; 25 milligrams per pound of body weight each following day. Divide total daily dose into 2 or 3 equal doses—administer at 12- or 8-hour intervals.
(2) Indications for use. For use as an adjunct to therapy of acute inflammatory and traumatic conditions of skeletal muscles. The drug provides relief of the signs of discomfort associated with myositis, muscle sprains, traumatic injuries, stifle injuries—especially when administered before or after surgery—and invertebral disc syndrome (can be used concurrently with adrenal corticosteroids).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.441   Chlortetracycline powder.
(a) Specifications. Chlortetracycline powder contains not less than 15 milligrams per gram chlortetracycline hydrochloride, or chlortetracycline bisulfate equivalent to 25.6, 64 or 102.4 grams per pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 069254 for use as in paragraph (d) of this section.
(2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (d)(4)(iv) of this section.
(3) Nos. 069043 and 076475 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) and (iii) of this section.
(c) Related tolerances. See § 556.150 of this chapter.
(d) Conditions of use. (1) Use as chlortetracycline hydrochloride in drinking water as follows:
(i) Swine —(A) Amount. Ten milligrams per pound of body weight daily in divided doses.
( 1 ) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae ( Haemophilus spp.), and Klebsiella spp.
( 2) Limitations. Prepare a fresh solution twice daily; as sole source of chlortetracycline; administer for not more than 5 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B) [Reserved]
(ii) [Reserved]
(2) Use as chlortetracycline hydrochloride in a drench or drinking water as follows:
(i) Calves —(A) Amount. Ten milligrams per pound of body weight daily in divided doses.
( 1 ) Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia (shipping fever) associated with Pasteurella spp., A. pleuropneumoniae ( Haemophilus spp.), and Klebsiella spp.
( 2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; administer for not more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B) [Reserved]
(ii) [Reserved]
(3) [Reserved]
(4) The following uses of chlortetracycline hydrochloride or chlortetracycline bisulfate in drinking water or drench were reviewed by the National Academy of Sciences/National Research Council (NAS/NRC) and found effective:
(i) Chickens —(A) Amount. 200 to 400 milligrams per gallon.
( 1 ) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae.
( 2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B) Amount. 400 to 800 milligrams per gallon.
( 1 ) Indications for use. Control of chronic respiratory disease and air-sac infections caused by M. gallisepticum and E. coli.
( 2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(C) Amount. One thousand milligrams per gallon.
( 1 ) Indications for use. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.
( 2 ) Limitations. See paragraph (d)(4)(i)(A)( 2 ) of this section.
(ii) Growing turkeys —(A) Amount. 400 milligrams per gallon.
( 1 ) Indications for use. Control of infectious synovitis caused by M. synoviae.
( 2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B) Amount. 25 milligrams per pound of body weight daily.
( 1 ) Indications for use. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis).
( 2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(iii) Swine —(A) Amount. 10 milligrams per pound body weight daily in divided doses.
(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. And bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae ( Haemophilus spp.), and Klebsiella spp.
(C) Limitations. Prepare fresh solution daily as the sole source of chlortetracycline. Do not use for more than 5 days. For Nos. 066104, 069043, 069254, and 076475: Do not slaughter animals for food within 5 days of treatment. For No. 069254: Do not slaughter animals for food within 24 hours of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(iv) Calves, beef cattle, and nonlactating dairy cattle —(A) Amount. 10 milligrams per pound daily in divided doses.
(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. And bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., A. pleuropneumoniae ( Haemophilus spp.), and Klebsiella spp.
(C) Limitations. Prepare fresh solution daily; use as a drench; as sole source of chlortetracycline; do not use for more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not use in lactating cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(5) Use in a drench or drinking water as follows:
(i) Chickens —(A) Amount. 200 to 400 mg/gal, for 7 to 14 days.
( 1 ) Indications for use. Control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline.
( 2 ) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 14 consecutive days; do not use in laying chickens; do not administer to chickens within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B) Amount. 400 to 800 mg/gal, for 7 to 14 days.
( 1 ) Indications for use. Control of chronic respiratory disease (CRD) and air-sac infections caused by M. gallisepticum and E. coli susceptible to chlortetracycline.
( 2 ) Limitations. As in paragraph (d)(5)(i)(A)( 2 ) of this section.
(C) Amount. One thousand mg/gal, for 7 to 14 days.
( 1 ) Indications for use. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.
( 2 ) Limitations. As in paragraph (d)(5)(i)(A)( 2 ) of this section.
(ii) Growing Turkeys —(A) Amount. 400 mg/gal, for 7 to 14 days.
( 1 ) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.
( 2 ) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 14 consecutive days; do not administer to growing turkeys within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B) Amount. 25 mg/lb body weight daily, for 7 to 14 days.
( 1 ) Indications for use. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.
( 2 ) Limitations. As in paragraph (d)(5)(ii)(A)( 2 ) of this section.
(iii) Swine —(A) Amount. 10 mg/lb body weight daily, for 3 to 5 days.
(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae , and Klebsiella spp. Susceptible to chlortetracycline.
(C) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 5 days; do not administer to swine within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(iv) Calves, beef cattle, and nonlactating dairy cattle —(A) Amount. 10 mg/lb body weight daily in divided doses, for 3 to 5 days.
(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. Susceptible to chlortetracycline.
(C) Limitations. Prepare fresh solution daily; use as a drench; use as the sole source of chlortetracycline; do not use for more than 5 days; do not administer to cattle within 24 hours of slaughter; do not use in lactating dairy cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.443   Chlortetracycline tablets and boluses.
(a) Specifications. Each tablet contains 25 milligrams (mg) chlortetracycline hydrochloride; each bolus contains 250 or 500 mg chlortetracycline hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 069043 for use of a 250-mg bolus as in paragraph (d)(1) of this section.
(2) No. 016592 for use of a 25-mg tablet as in paragraph (d)(2) of this section.
(3) No. 016592 for use of a 500-mg bolus as in paragraph (d)(3) of this section.
(c) Related tolerances. See § 556.150 of this chapter.
(d) Conditions of use in calves —(1) Amount. One 250 milligram bolus per 50 pounds of body weight twice a day for 3 to 5 days.
(i) Indications for use. Treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Klesbsiella spp., and Haemophilus spp.
(ii) Limitations. Administer bolus directly by mouth or crush and dissolve in milk or water for drenching or bucket feeding. Do not use for more than 5 days. Do not administer within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Amount. One 25 milligram tablet for each 5 pounds of body weight every 12 hours daily for 3 to 5 days.
(i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. And bacterial pneumonia associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.
(ii) Limitations. Administer tablet directly by mouth or crush and dissolve in water for drenching; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; when feeding milk or milk replacer, administration 1 hour before or 2 hours after feeding; do not administer within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Amount. One 500 milligram bolus per 100 pounds of body weight twice a day for 3 to 5 days.
(i) Indications for use. Treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.
(ii) Limitations. Do not use for more than 5 days. Do not administer within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.445   Chlortetracycline and sulfamethazine powder.
(a) Specifications. Each pound of soluble powder contains chlortetracycline bisulfate equivalent to 102.4 grams (g) of chlortetracycline hydrochloride and sulfamethazine bisulfate equivalent to 102.4 g of sulfamethazine.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.150 and 556.670 of this chapter.
(d) Conditions of use in swine. Administer in drinking water as follows:
(1) Amount. 250 milligrams (mg) of chlortetracycline and 250 mg of sulfamethazine per gallon.
(2) Indications for use. For the prevention and treatment of bacterial enteritis; as an aid in the reduction of the incidence of cervical abscesses; and as an aid in the maintenance of weight gains in the presence of bacterial enteritis and atrophic rhinitis.
(3) Limitations. Use as the sole source of chlortetracycline and sulfonamide. Not to be used for more than 28 consecutive days. Withdraw 15 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.446   Clindamycin capsules and tablets.
(a) Specifications. (1) Each capsule contains the equivalent of 25, 75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.
(2) Each tablet contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.
(3) Each capsule contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 054771 and 069043 for use of capsules described in paragraph (a)(1) of this section.
(2) No. 051311 for use of tablets described in paragraph (a)(2) of this section.
(3) No. 043806 for use of tablets described in paragraph (a)(3) of this section.
(c) Conditions of use in dogs —(1) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.
(2) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. intermedius ), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis , Prevotella melaninogenicus , Fusobacterium necrophorum , and Clostridium perfringens , dental infections due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens , and osteomyelitis due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.447   Clindamycin solution.
(a) Specifications. Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.
(b) Sponsors. See Nos. 051311, 054771, 058829, 061133, and 069043 in § 510.600(c) of this chapter.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Dogs —(i) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.
(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. intermedius ), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis , Prevotella melaninogenicus , Fusobacterium necrophorum , and Clostridium perfringens ; dental infections due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens ; and osteomyelitis due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens.
(2) Cats—(i) Amount. 5.0 to 15.0 mg/lb body weight every 24 hours for a maximum of 14 days.
(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of Staphylococcus aureus , S. intermedius , Streptococcus spp. ; deep wounds and abscesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis ; and dental infections due to susceptible strains of S. aureus , S. intermedius , Streptococcus spp. , C. perfringens , and B. fragilis.
§ 520.452   Clenbuterol syrup.
(a) Specifications. Each milliliter contains 72.5 micrograms of clenbuterol hydrochloride.
(b) Sponsor. See 000010 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use —(1) Horses —(i) Amount. Administer orally twice a day (b.i.d.). Initial dose is 0.5 milliliter per 100 pounds body weight (0.8 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1 milliliter per 100 pounds (1.6 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 milliliters per 100 pounds (2.4 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 2.0 milliliters per 100 pounds (3.2 micrograms per kilogram) for 3 days (6 treatments). If no improvement, horse is nonresponder to clenbuterol and treatment should be discontinued.
(ii) Indications for use. Indicated for the management of horses affected with airway obstruction, such as occurs in chronic obstructive pulmonary disease (COPD).
(iii) Limitations. Treat at effective dose for 30 days. At the end of the 30-day treatment period, drug should be withdrawn. If signs return, the 30-day treatment period may be repeated. If repeating treatment, the step-wise dosage schedule should be repeated. The effect of this drug on breeding stallions and brood mares has not been determined. Treatment starting with dosages higher than the initial dose is not recommended. Federal law prohibits the extralabel use of this drug in food animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 520.455   Clomipramine.
(a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.
(b) Sponsors. See Nos. 051311 and 086039 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. 2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.
(2) Indications for use. For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.462   Clorsulon drench.
(a) Specifications. The drug is a suspension containing 8.5 percent clorsulon (85 milligrams per milliliter).
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.163 of this chapter.
(d) Conditions of use. Cattle —(1) Amount. One-quarter fluid ounce per 200 pounds of body weight (7 milligrams per kilogram or 3.2 milligrams per pound of body weight).
(2) Indications for use. For the treatment of immature and adult liver fluke ( Fasciola hepatica ) infestations in cattle.
(3) Limitations. Using dose syringe, deposit drench over back of tongue. Do not treat cattle within 8 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.522   Cyclosporine.
(a) Specifications. (1) Each cyclosporine capsule, USP (MODIFIED) contains 10, 25, 50, or 100 milligrams (mg) cyclosporine.
(2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) contains 100 mg cyclosporine.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter.
(1) No. 058198 for use of products described in paragraph (a) as in paragraph (d) of this section.
(2) No. 017033 for use of product described in paragraph (a)(1) as in paragraph (d)(1) of this section.
(3) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(1) of this section.
(4) No. 013744 for use of product described in paragraph (a)(2) as in paragraph (d) of this section.
(c) [Reserved]
(d) Conditions of use —(1) Dogs. Use capsules described in paragraph (a)(1) of this section as follow:
(i) Amount. Administer 5 mg per kilogram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect.
(ii) Indications for use. For the control of atopic dermatitis in dogs weighing at least 4 pounds.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats. Use the solution described in paragraph (a)(2) of this section as follow:
(i) Amount. Administer 7 mg/kg of body weight orally as a single daily dose for a minimum of 4 to 6 weeks or until resolution of clinical signs. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or twice weekly to maintain the desired therapeutic effect.
(ii) Indications for use. For the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.530   Cythioate oral liquid.
(a) Specifications. Each milliliter contains 15 milligrams of cythioate.
(b) Sponsor. See Nos. 054771 and 058198 in § 510.600 of this chapter.
(c) Conditions of use —(1) Amount. 15 milligrams cythioate per 10 pounds of body weight every third day or twice a week.
(2) Indications for use. Dogs, for control of fleas.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.531   Cythioate tablets.
(a) Specifications. Each tablet contains 30 or 90 milligrams (mg) cythioate.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) No. 058198 for use of 30- and 90-mg tablets.
(2) No. 054771 for use of the 30-mg tablet.
(c) Conditions of use —(1) Amount. 30 milligrams cythioate per 20 pounds of body weight every third day or twice a week.
(2) Indications for use. Dogs, for control of fleas.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.534   Decoquinate.
(a) Specifications. Each gram of powder contains 8 milligrams (0.8 percent) decoquinate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.170 of this chapter.
(d) Conditions of use. Calves —(1) Amount. Feed 22.7 milligrams per 100 pounds of body weight (0.5 milligram per kilogram) per day.
(2) Indications for use. For the prevention of coccidiosis in ruminating and nonruminating calves, including veal calves, caused by Eimeria bovis and E. zuernii.
(3) Limitations. Feed in whole milk at the rate of 22.7 milligrams per 100 pounds body weight daily (0.5 milligram per kilogram) for at least 28 days.
§ 520.538   Deracoxib.
(a) Specifications. Each tablet contains 12, 25, 50, 75, or 100 milligrams (mg) deracoxib.
(b) Sponsors. See Nos. 013744, 058198, and 086101 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally as needed, as a single daily dose based on body weight:
(i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use as in paragraph (d)(2)(i) of this section.
(ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in paragraph (d)(2)(ii) of this section.
(iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(iii) of this section.
(2) Indications for use. (i) For the control of pain and inflammation associated with osteoarthritis.
(ii) For the control of postoperative pain and inflammation associated with dental surgery.
(iii) For the control of postoperative pain and inflammation associated with orthopedic surgery.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.540   Dexamethasone oral dosage forms.
§ 520.540a   Dexamethasone powder.
(a) Specifications. Each packet contains 10 milligrams (mg) of dexamethasone.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in cattle and horses —(1) Amount. Administer 5 to 10 mg per animal the first day then 5 mg per day as required by drench or by sprinkling on a small amount of feed.
(2) Indications for use. As supportive therapy following parenteral steroid administration for management or inflammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption.
§ 520.540b   Dexamethasone tablets and boluses.
(a)(1) Specifications. Each bolus is half-scored and contains 10 milligrams of dexamethasone.
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Conditions of use in cattle and horses —(i) Amount. Administer orally 5 to 10 milligrams on the first day, then 5 milligrams per day as required.
(ii) Indications for use. As supportive therapy following parenteral steroid administration for management or inflammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption.
(b)(1) Specifications. Each tablet contains 0.25 milligram of dexamethasone.
(2) Sponsors. See Nos. 000061 and 061133 in § 510.600(c) of this chapter.
(3) Conditions of use in dogs and cats —(i) Amount. Dogs: Administer orally 0.25 to 1.25 milligrams per day for up to 7 days. Cats: Administer orally 0.125 to 0.5 milligrams per day for up to 7 days.
(ii) Indications for use. As an anti-inflammatory agent.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.540c   Dexamethasone chewable tablets.
(a) Specifications. Each half-scored tablet contains 0.25 milligram of dexamethasone.
(b) Sponsor. See No. 051031 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer by free-choice feeding or crumbled over food 0.25 to 1.25 milligrams daily in single or two divided doses until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced by 0.125 milligram per day until maintenance level is achieved.
(2) Indications for use. As supportive therapy in nonspecific dermatosis and inflammatory conditions.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.563   Diatrizoate.
(a) Specifications. Diatrizoate meglumine oral solution is a water soluble radiopaque medium containing 66 percent diatrizoate meglumine and 10 percent diatrizoate sodium.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer orally 0.5 to 1.0 milliliter per pound of body weight by gavage or stomach tube. Administered rectally 0.5 to 1.0 milliliter per pound of body weight diluted with 1 part of the drug to 5 parts of water.
(2) Indications for use. For radiography of the gastrointestinal tract.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.580   Dichlorophene and toluene.
(a) Specifications. Each capsule contains 50 milligrams (mg) of dichlorophene and 60 mg of toluene, or multiples thereof.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) Nos. 017135 and 023851 for use only as a single dose.
(2) Nos. 000061, 054771, and 069043 for use in a single dose or divided-dosage regimen.
(c) Required statement. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism, and before administering to weak or debilitated animals.
(d) Conditions of use —(1) Amount. Administer as follows:
(i) Single dose: Administer 100 mg of dicholorophene and 120 mg of toluene per pound of body weight.
(ii) Divided dose: Administer 100 mg of dichlorophene and 120 mg of toluene per 5 pounds of body weight (20 and 24 mg per pound) daily for 6 days.
(2) Indications for use. For the removal of ascarids ( Toxocara canis and Toxascaris leonina ) and hookworms ( Ancylostoma caninum and Uncinaria stenocephala ); and as an aid in removing tapeworms ( Taenia pisiformis, Dipylidium caninum, and Echinococcus granulosus ) from dogs and cats.
(3) Limitations. Withhold solid foods and milk for at least 12 hours prior to medication and for 4 hours afterward. Repeat treatment in 2 to 4 weeks in animals subject to reinfection.
§ 520.581   Dichlorophene tablets.
(a) Specifications. Each tablet contains 1 gram of dichlorophene.
(b) Sponsor. See 023851 in § 510.600(c) of this chapter.
(c) Required statement. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism, and before administering to weak or debilitated animals.
(d) Conditions of use. Dogs —(1) Amount. Single dose of 1 tablet (1 gram of dichlorophene) for each 10 pounds of body weight.
(2) Indications for use. It is used as an aid in the removal of tapeworms ( Taenia pisiformis and Dipylidium caninum ).
(3) Limitations. Withhold solid foods and milk for at least 12 hours prior to medication and for 4 hours afterward.
§ 520.596   Dichlorvos powder.
(a) Specifications —(1) Each 2-ounce packet contains 2.27 grams (4 percent) dichlorvos.
(2) Each milligram of powder contains 2.27 milligrams (mg) dichlorvos.
(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter for use of the product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section and the product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
(c) Related tolerances. See § 556.180 of this chapter.
(d) Conditions of use —(1) Swine (adult gilts, sows, and boars) —(i) Amount. Add powder to the indicated amount of feed and administered shortly after mixing, as follows:
(ii) Indications for use. For the removal and control of sexually mature (adult), sexually immature and/or 4th stage larvae of the whipworm ( Trichuris suis ), nodular worms ( Oesophagostomum spp.), large round-worm ( Ascaris suum ), and the mature thick stomach worm ( Ascarops strongylina ) occurring in the lumen of the gastrointestinal tract of pigs, boars, and open or bred gilts and sows.
(iii) Limitations. Do not use this product on animals either simultaneously or within a few days before or after treatment with or exposure to cholinesterase inhibiting drugs, pesticides, or chemicals. The preparation should be mixed thoroughly with the feed on a clean, impervious surface. Do not allow swine access to feed other than that containing the preparation until treatment is complete. Do not treat pigs with signs of scours until these signs subside or are alleviated by proper medication. Resume normal feeding schedule afterwards. Swine may be retreated in 4 to 5 weeks.
(2) Horses —(i) Amount. Administer in the grain portion of the ration at a dosage of 14.2 to 18.5 mg per pound of body weight as a single dose. Administered at one-half of the single recommended dosage and repeated 8 to 12 hours later in the treatment of very aged, emaciated, or debilitated subjects or those reluctant to consume medicated feed. In suspected cases of severe ascarid infection sufficient to cause concern over mechanical blockage of the intestinal tract, the split dosage should be used.
(ii) Indications for use. For the removal and control of bots ( Gastrophilus intestinalis, G. nasalis ), large strongyles ( Strongylus vulgaris, S. equinus, S. edentatus ), small strongyles (of the genera Cyathostomum, Cylicocercus, Cylicocyclus, Cylicodontophorus, Triodontophorus, Poteriostomum, Gyalocephalus ), pinworms ( Oxyuris equi ), and large roundworm ( Parascaris equorum ) in horses including ponies and mules. Not for use in foals (sucklings and young weanlings).
(iii) Limitations. Do not use in horses which are severely debilitated, suffering from diarrhea or severe constipation, infectious disease, toxemia, or colic. Do not administer in conjunction with or within 1 week of administration of muscle relaxant drugs, phenothiazine derived tranquilizers or central nervous system depressant drugs. Horses should not be subjected to insecticide treatment for 5 days prior to or after treating with the drug. Do not administer to horses afflicted with chronic alveolar emphysema (heaves) or related respiratory conditions. The product is a cholinesterase inhibitor and should not be used simultaneously or within a few days before or after treatment with or exposure to cholinesterase inhibiting drugs, pesticides or chemicals. Do not use in animals other than horses, ponies, and mules. Do not use in horses, ponies, and mules intended for food purposes. Do not allow fowl access to feed containing this preparation or to fecal excrement from treated animals.
§ 520.598   Dichlorvos tablets.
(a) Specifications. Each tablet contains 2, 5, 10, or 20 milligrams (mg) dichlorvos.
(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs, puppies, cats, and kittens —(1) Amount. Administer orally at 5 mg dichlorvos per pound of body weight.
(2) Indications for use —(i) Dogs and puppies: Removal and control of intestinal roundworms ( Toxocara canis and Toxascaris leonina ) and hookworms ( Ancylostoma caninum and Uncinaria stenocephala ).
(ii) Cats and kittens: Removal and control of intestinal roundworms ( Toxocara cati and Toxascaris leonina ) and hookworms ( Ancylostoma tubaeforme and Uncinaria stenocephala ).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.600   Dichlorvos capsules and pellets.
(a) Specifications. Each capsule contains 2.27 milligrams (mg) (4 percent) dichlorvos.
(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer any combination of capsules and/or pellets so that the animal receives a single dose equaling 12 to 15 mg of dichlorvos per pound of body weight.
(2) Indications for use. For removal of Toxocara canis and Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in the lumen of the gastrointestinal tract.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.602   Dichlorvos gel.
(a) Specifications. Each milligram (mg) of gel contains 2.27 milligrams (mg) dichlorvos.
(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 20 mg per kilogram of body weight for the removal of bots and ascarids. Repeat administration every 21 to 28 days for the control of bots and ascarids. For the control of bots only, the repeat dosage is 10 milligrams per kilogram of body weight every 21 to 28 days during bot fly season.
(2) Indications for use. For the removal and control of first, second, and third instar bots ( Gastrophilus intestinalis and G. nasalis ), sexually mature and sexually immature (4th stage) ascarids ( Parascaris equorum ) in horses and foals.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.606   Diclazuril.
(a) Specifications. Each 100 grams (g) of pellets contain 1.56 g diclazuril.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 1 milligram (mg) per kilogram (0.45 mg per pound) of body weight in the daily grain ration for 28 days.
(2) Indications for use. For the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.608   Dicloxacillin.
(a) Specifications. Each capsule contains dicloxacillin sodium monohydrate equivalent to 50, 100, 200, or 500 milligrams of dicloxacillin.
(b) Sponsor. See No. 054771 in § 510.600 (c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally 5 to 10 milligrams per pound of body weight, three times daily. In severe cases, up to 25 milligrams per pound of body weight three times daily.
(2) Indications for use. For the treatment of pyoderma (pyogenic dermatitis) due to penicillinase-producing staphylococci sensitive to dicloxacillin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.620   Diethylcarbamazine oral dosage forms.
§ 520.622   Diethylcarbamazine citrate oral dosage forms.
§ 520.622a   Diethylcarbamazine citrate tablets.
(a) Sponsors. (1) [Reserved]
(2) See 054771 in § 510.600(c) of this chapter for use of 100, 200, and 300 milligram tablets for prevention of heartworm disease in dogs and as an aid in the treatment of ascarid infections in dogs.
(3) See 061133 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.
(4) [Reserved]
(5) See No. 000061 in § 510.600(c) of this chapter for use of 60, 120, or 180 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.
(6) See No. 069043 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.
(b) Conditions of use —(1) Dosage/indications for use. (i) Three milligrams per pound of body weight daily for prevention of heartworm disease ( Dirofilaria immitis ) in dogs.
(ii) Three milligrams per pound of body weight daily as an aid in the control of ascarid infections ( Toxocara canis ) in dogs.
(iii) Twenty-five to 50 milligrams per pound of body weight as an aid in the treatment of ascarid infections in dogs ( Toxocara canis ) and cats ( Toxocara canis and Toxascaris leonina ).
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.622b   Diethylcarbamazine citrate syrup.
(a)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.
(2) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is indicated for use in dogs for the prevention of infection with Dirofilaria immitis and T. canis and T. leonina. It is also indicated for treatment of ascarid infections of T. canis and T. leonina in dogs and T. cati in cats.
(ii) For prevention of heartworm and ascarid infections in dogs, the drug may be added to the daily diet at a dosage rate of 3.0 milligrams per pound of body weight per day or given directly by mouth at the same dosage rate. For treatment of ascarid infections in dogs and cats, the drug is administered at a dosage level of 25 to 50 milligrams per pound of body weight preferably administered immediately after feeding.
(iii) Older dogs should be proven negative for the presence of Dirofilaria immitis infection before administration of the drug. Those with proven infection of Dirofilaria immitis should be rendered negative using adulticidal and microfilaricidal drugs before administration of this drug.
(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(b) [Reserved]
(c)(1) Specifications. Each milliliter of syrup contains 60 milligrams of diethylcarbamazine citrate.
(2) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(3) Conditions of use. (i) The drug is used in dogs between 4 weeks and 8 months of age for the removal of ascarids ( Toxacara canis ) and in animals over 4 weeks of age for the prevention of heartworm disease ( Dirofilaria immitis ).
(ii) The drug is administered ( a ) for removal of ascarids at a dosage of 50 milligrams per pound of body weight divided into two equal doses and administered 8 to 12 hours apart (morning and night), orally or mixed with either dry or wet food, and ( b ) for prevention of heartworm disease at a dosage of 3 milligrams per pound of body weight daily, orally or in food, in heartworm endemic areas, from the beginning of mosquito activity, during the mosquito season, and for 2 months following the end thereof.
(iii) Dogs older than 8 months of age may be infected with Dirofilaria immitis. Use of the drug is contraindicated in dogs with active D. immitis infections.
(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.622c   Diethylcarbamazine citrate chewable tablets.
(a) Specifications. Each chewable tablet contains 30, 45, 60, 120, 150, or 180 milligrams of diethylcarbamazine citrate.
(b) Sponsors. See drug listing nos. in § 510.600(c) of this chapter for identification of sponsors as follows:
(1) [Reserved]
(2) For 054771, use of 60, 120, or 180 milligram tablets as in paragraph (c)(2)(ii) of this section.
(3) For 061690, use of 45 or 150 milligram tablets as in paragraph (c)(2)(iii) of this section.
(4) For 061133, use of 60-, 120-, or 180-milligram tablets as in paragraph (c)(2)(i) of this section.
(5) For 000061, use of 60-milligram tablets as in paragraph (c)(2)(i) of this section.
(6) For 069043, use of 30, 60, 120, or 180 milligram tablets as in paragraph (c)(2)(i) of this section.
(c) Conditions of use —(1) Amount. 3 milligrams per pound of body weight per day for prevention of heartworm disease and control of ascarids; 25 to 50 milligrams per pound of body weight as an aid in treatment of ascarid infections.
(2) Indications for use. (i) For prevention of heartworm disease ( Dirofilaria immitis ) in dogs; as an aid in control of ascarids ( Toxocara canis ) in dogs; as an aid in treatment of ascarid ( Toxocara canis and Toxascaris leonina ) infections in dogs and cats.
(ii) For prevention of infection with Dirofilaria immitis (heartworm disease) in dogs; as an aid in treatment of ascarid ( Toxocara canis and Toxascaris leonina ) infections in dogs.
(iii) For prevention of heartworm disease ( Dirofilaria immitis ) in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.623   Diethylcarbamazine and oxibendazole chewable tablets.
(a) Specifications. Each tablet contains either 60, 120, or 180 milligrams of diethylcarbamazine citrate with 45, 91, or 136 milligrams of oxibendazole, respectively.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally to dogs at a dosage level of 6.6 milligrams of diethylcarbamazine citrate per kilogram of body weight (3 milligrams per pound of body weight) and 5.0 milligrams of oxibendazole per kilogram of body weight (2.27 milligrams per pound of body weight).
(2) Indications for use. For prevention of infection with Dirofilaria immitis (heartworm disease) and Ancylostoma caninum (hookworm infection) and for removal and control of Trichuris vulpis (whipworm infection) and mature and immature stages of intestinal Toxocara canis (ascarid infection).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.666   Dirlotapide.
(a) Specifications. Each milliliter (mL) of solution contains 5 milligrams (mg) dirlotapide.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. The initial dosage is 0.01 mL/kg (0.0045 mL/lb) body weight for the first 14 days. After the first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg (0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of treatment). Dogs should be weighed monthly and the dose volume adjusted every month, as necessary, to maintain a target percent weight loss until the desired weight is achieved.
(2) Indications for use. For the management of obesity.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.763   Dithiazanine oral dosage forms.
§ 520.763a   Dithiazanine tablets.
(a) Specifications. Each tablet contains 10, 50, 100, or 200 milligrams (mg) dithiazanine iodide.
(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Indications for use and amount. Administer orally immediately after feeding as follows:
(i) For large roundworms ( Toxocara canis, Toxascaris leonina ): 10 mg per pound (/lb) of body weight for 3 to 5 days;
(ii) For hookworms ( Ancylostoma caninum, Uncinaria stenocephala ) and whipworms ( Trichuris vulpis ): 10 mg/lb of body weight for 7 days;
(iii) For Strongyloides ( Strongyloides canis, Strongyloides stercoralis ): 10 mg/lb of body weight for 10 to 12 days;
(iv) For heartworm microfilariae ( Dirofilaria immitus ): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment for heartworm microfilariae should follow 6 weeks after therapy for adult worms.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.763b   Dithiazanine powder.
(a) Specifications. Each tablespoon of powder contains 200 milligrams (mg) dithiazanine iodide.
(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Indications for use and amount. Administer orally by mixing in food as follows:
(i) For large roundworms ( Toxocara canis, Toxascaris leonina ): 10 mg per pound (/lb) of body weight for 3 to 5 days;
(ii) For hookworms ( Ancylostoma caninum, Uncinaria stenocephala ) and whipworms ( Trichuris vulpis ): 10 mg/lb of body weight for 7 days;
(iii) For Strongyloides ( Strongyloides canis, Strongyloides stercoralis ): 10 mg/lb of body weight for 10 to 12 days;
(iv) For heartworm microfilariae ( Dirofilaria immitus ): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment for heartworm microfilariae should follow 6 weeks after therapy for adult worms.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.763c   Dithiazanine iodide and piperazine citrate suspension.
(a) Specifications. Each milliliter of suspension contains 69 milligrams (mg) dithiazanine iodide and 83 mg piperazine base (as piperazine citrate).
(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 1 ounce (30 milliliters) per 100 pounds of body weight for the first 500 pounds; 3/4 ounce for each 100 pounds thereafter, up to 1,200 pounds; 10 1/4 ounces to animals over 1,200 pounds.
(2) Indications for use. For control of large roundworms, Parascaris equorum; small strongyles; large strongyles, Strongylus vulgaris; and pinworms, Oxyuris equi.
(3) Limitations. Administer by drench or mixed with the daily ration as a single dose. Treatment is recommended in spring and fall. In a heavily infested environment, treatment may be repeated every 30 days. Not for use in horses intended for food purposes. Severely debilitated animals should not be wormed except on the advice of a veterinarian. If the drug is for administration by stomach tube, it shall be labeled: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
§ 520.766   Domperidone.
(a) Specifications. Each milliliter of gel contains 110 milligrams (mg) domperidone.
(b) Sponsor. See No. 043264 in § 510.600 of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 0.5 mg per pound (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to 15 days prior to the expected foaling date. Treatment may be continued for up to 5 days after foaling if mares are not producing adequate milk.
(2) Indications for use. For prevention of fescue toxicosis in periparturient mares.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.784   Doxylamine.
(a) Specifications. The drug is in tablet form and contains doxylamine succinate as the active drug ingredient.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Horses: Administer orally 1 to 2 milligrams (mg) per pound (/lb) of body weight per day divided into 3 or 4 equal doses. Dogs and cats: Administer orally 2 to 3 mg/lb of body weight per day divided into 3 or 4 equal doses.
(2) Indications for use. For use when antihistaminic therapy may be expected to alleviate some signs of disease in horses, dogs, and cats.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.812   Enrofloxacin.
(a) Specifications. (1) Each tablet contains:
(i) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
(ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
(2) Each chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.
(3) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section.
(1) No. 058198 for use of products described in paragraph (a) of this section.
(2) Nos. 017033 and 086117 for use of product described in paragraph (a)(1)(i) of this section.
(3) Nos. 055529 and 086101 for use of product described in paragraph (a)(2) of this section.
(c) Conditions of use in dogs and cats —(1) Amount. Administer orally as a single, daily dose or divided into two equal doses at 12-hour intervals.
(i) Dogs. 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound (/lb)) of body weight.
(ii) Cats. 5 mg/kg (2.27 mg/lb) of body weight.
(2) Indications for use. For the management of diseases associated with bacteria susceptible to enrofloxacin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.
§ 520.816   Epsiprantel.
(a) Specifications. Each tablet contains either 12.5, 25, 50, or 100 milligrams of epsiprantel.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. 2.5 milligrams per pound of body weight.
(ii) Indications for use. Removal of canine cestodes Dipylidium caninum and Taenia pisiformis.
(2) Cats —(i) Amount. 1.25 milligrams per pound of body weight.
(ii) Indications for use. Removal of feline cestodes D. caninum and T. taeniaeformis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.823   Erythromycin.
(a) Specifications. Each gram of powder contains erythromycin phosphate equivalent to 0.89 gram of erythromycin master standard.
(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.230 of this chapter.
(d) Conditions of use. It is used in drinking water as follows:
(1) Broiler and replacement chickens —(i) Amount. Administer 0.500 gram per gallon for 5 days.
(ii) Indications for use. As an aid in the control of chronic respiratory disease due to Mycoplasma gallisepticum susceptible to erythromycin.
(iii) Limitations. Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Replacement chickens and chicken breeders —(i) Amount. Administer 0.500 gram per gallon for 7 days.
(ii) Indications for use. As an aid in the control of infectious coryza due to Haemophilus gallinarum susceptible to erythromycin.
(iii) Limitations. Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Growing turkeys —(i) Amount. Administer 0.500 gram per gallon for 7 days.
(ii) Indications for use. As an aid in the control of blue comb (nonspecific infectious enteritis) caused by organisms susceptible to erythromycin.
(iii) Limitations. Do not use in turkeys producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.852   Estriol.
(a) Specifications. Each tablet contains 1 milligram (mg) estriol.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer at an initial dose of 2 mg per dog per day. The dosage may be titrated to as low as 0.5 mg per dog every second day, depending on response.
(2) Indications for use. For the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.863   Ethylisobutrazine.
(a) Specifications. Each tablet contains either 10 milligrams or 50 milligrams of ethylisobutrazine hydrochloride.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally 2 to 5 milligrams per pound of body weight once daily.
(2) Indications for use. As a tranquilizer.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.903   Febantel oral dosage forms.
§ 520.903a   Febantel paste.
(a) Specifications. Each gram of paste contains 455 milligrams (45.5 percent) febantel.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer paste orally at 6 milligrams per kilogram (2.73 milligrams per pound) of body weight on the base of the tongue or well mixed into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks.
(2) Indications for use. For removal of large strongyles ( Strongylus vulgaris, S. edentatus, S. equinus ); ascarids ( Parascaris equorum —sexually mature and immature); pinworms ( Oxyuris equi —adult and 4th stage larva); and various small strongyles in horses, foals, and ponies.
(3) Limitations. Do not use in horses intended for human consumption. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.903b   Febantel suspension.
(a) Specifications. Each ounce of suspension contains 2.75 grams (9.3 percent ounce) febantel.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 3 milliliters per 100 pounds body weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body weight). Administer by stomach tube or drench, or by mixing well into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks.
(2) Indications for use. For removal of ascarids ( Parascaris equorum —adult and sexually immature), pinworms ( Oxyuris equi —adult and 4th stage larvae), large strongyles ( Strongylus vulgaris, S. edentatus, S. equinus ), and various small strongyles in horses, breeding stallions and mares, pregnant mares, foals, and ponies.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Special considerations. Febantel suspension may be used in combination with trichlorfon oral liquid in accordance with the provisions of § 520.2520c, this section, and the following conditions:
(1) Combine 1 part febantel suspension with 5 parts trichlorfon liquid.
(2) Allow animal to consume a portion of daily grain ration; administer mixture by stomach tube at rate of 18 milliliters per 100 pounds of body weight.
§ 520.903c   Febantel and praziquantel paste.
(a) Specifications. Each gram of paste contains 34 milligrams of febantel and 3.4 milligrams of praziquantel.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount —(i) Dogs and cats (over 6 months of age): 10 milligrams of febantel and 1 milligram of praziquantel per kilogram of body weight (1 gram of paste per 7.5 pounds body weight) administered by mouth or in the food once daily for 3 days.
(ii) Puppies and kittens (less than 6 months of age): 15 milligrams of febantel and 1.5 milligrams of praziquantel per kilogram of body weight (1 gram of paste per 5 pounds body weight) administered by mouth on a full stomach once daily for 3 days.
(2) Indications for use. (i) Dogs and puppies: For removal of hookworms ( Ancylostoma caninum and Uncinaria stenocephala ), whipworms ( Trichuris vulpis ), ascarids ( Toxocara canis and Toxascaris leonina ), and tapeworms ( Dipylidium caninum and Taenia pisiformis ).
(ii) Cats and kittens: For removal of hookworms ( Ancylostoma tubaeforme ), ascarids ( Toxocara cati ) and tapeworms ( Dipylidium caninum and Taenia taeniaeformis ).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.903d   Febantel tablets.
(a) Specifications. Each scored tablet contains 27.2 milligrams of febantel for use in dogs, puppies, cats, and kittens or 163.3 milligrams of febantel for use in dogs, puppies, and cats.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount —(i) Dogs and cats. Ten milligrams per kilogram body weight. Administer once daily for 3 consecutive days.
(ii) Puppies and kittens fewer than 6 months of age. Fifteen milligrams per kilogram body weight. Administer once daily for 3 consecutive days.
(2) Indications for use. (i) For removal of hookworms ( Ancylostoma caninum and Uncinaria stenocephala ), ascarids ( Toxocara canis and Toxascaris leonina ) and whipworms ( Trichuris vulpis ) in dogs and puppies.
(ii) For removal of hookworms ( Ancylostoma tubaeforme ) and ascarids ( Toxocara cati ) in cats and kittens.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.905   Fenbendazole oral dosage forms.
§ 520.905a   Fenbendazole suspension.
(a) Specifications. Each milliliter of suspension contains 100 milligrams (mg) fenbendazole for use as in paragraphs (e)(1), (2), (3), and (4) of this section; or 200 mg fenbendazole for use as in paragraphs (e)(5) and (6) of this section.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.275 of this chapter.
(d) Special considerations. (1) See § 500.25 of this chapter.
(2) Fenbendazole suspension 10 percent and approved forms of trichlorfon, when used concomitantly for treating the indications provided in paragraph (e) of this section and for treating infections of stomach bot as provided in § 520.2520, have been shown to be compatible and not to interfere with one another.
(e) Conditions of use —(1) Horses —(i) Amount. Administer orally 5 mg per kilogram (/kg) (2.3 mg per pound (/lb)) for the control of large strongyles, small strongyles, and pinworms; 10 mg/kg for the control of ascarids.
(ii) Indications for use. For the treatment and control of large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus species), small strongyles ( Cyathostomum species, Cylicocyclus species, Cylicostephanus species, Cylicodontophorus species), pinworms ( Oxyuris equi ) and ascarids ( Parascaris equorum ).
(iii) Limitations. Do not use in horses intended for human consumption.
(2) Beef and dairy cattle —(i) Amount. Administer orally 2.3 mg/lb of body weight (5 mg/kg).
(ii) Indications for use. For the treatment and control of: Lungworms: Adult ( Dictyocaulus viviparus ); Stomach worms: Adult brown stomach worms ( Ostertagia ostertagi ); adult and fourth-stage larvae barberpole worms ( Haemonchus contortus and H. placei ); adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei ); Intestinal worms (adult and fourth-stage larvae): Hookworms ( Bunostomum phlebotomum ), thread-necked intestinal worms ( Nematodirus helvetianus ), small intestinal worms ( Cooperia punctata and C. oncophora ), bankrupt worms ( Trichostrongylus colubriformis ), and nodular worms ( Oesophagostomum radiatum ).
(iii) Limitations. Milk taken from cows during treatment and for 48 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves.
(3) Beef cattle —(i) Amount. Administer orally 4.6 mg/lb of body weight (10 mg/kg).
(ii) Indications for use. For the treatment and control of stomach worms (fourth-stage inhibited larvae/type II ostertagiasis), Ostertagia ostertagi, and tapeworms, Moniezia benedeni.
(iii) Limitations. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Goats —(i) Amount. Administer orally 2.3 mg/lb of body weight (5 mg/kg).
(ii) Indications for use. For the treatment and control of stomach worms (adults) Haemonchus contortus and Teladorsagia circumcincta.
(iii) Limitations. Goats must not be slaughtered for human consumption within 6 days following last treatment with this drug product. Because a milk discard time has not been established, do not use in lactating goats.
(5) Chickens —(i) Amount. Administer orally via drinking water at a daily dose of 1 mg/kg body weight (0.454 mg/lb) for 5 consecutive days.
(ii) Indications for use. For the treatment and control of adult Ascaridia galli in broiler chickens and replacement chickens, and for the treatment and control of adult A. galli and Heterakis gallinarum in breeding chickens and laying hens.
(6) Swine, except for nursing piglets —(i) Amount. Administer orally via the drinking water at a daily dose of 2.2 mg/kg of body weight (1.0 mg/lb) for 3 consecutive days.
(ii) Indications for use. For the treatment and control of: Lungworms: Adult Metastrongylus apri, Adult Metastrongylus pudendotectus; Gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms ( Ascaris suum ), Adult nodular worms ( Oesophagostomum dentatum, O. quadrispinulatum ), Adult small stomach worms ( Hyostrongylus rubidus ), Adult and larvae (L2, L3, L4 stages—intestinal mucosal forms) whipworms ( Trichuris suis ); and Kidney worms: Adult and larvae Stephanurus dentatus.
(iii) Limitations. Swine intended for human consumption must not be slaughtered within 2 days from the last treatment.
§ 520.905b   Fenbendazole granules.
(a) Specifications. Each gram of granules contains 222 milligrams (mg) fenbendazole.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Special considerations. See § 500.25 of this chapter.
(d) Conditions of use —(1) Horses —(i) Amount. 5 mg/kilogram (kg) for large strongyles, small strongyles, and pinworms; 10 mg/kg for ascarids.
(ii) Indications for use. For the control of infections of large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles, pinworms ( Oxyuris equi ), and ascarids ( Parascaris equorum ).
(iii) Limitations. Sprinkle the appropriate amount of drug on a small amount of the usual grain ration. Prepare for each horse individually. Withholding feed or water is not necessary. Retreat in 6 to 8 weeks if required. Do not use in horses intended for food.
(2) Dogs —(i) Amount. 50 mg/kg daily for 3 consecutive days.
(ii) Indications for use. For the treatment and control of ascarids ( Toxocara canis, Toxascaris leonina ), hookworms ( Ancylostoma caninum, Uncinaria stenocephala ), whipworms ( Trichuris vulpis ), and tapeworms ( Taenia pisiformis ).
(iii) Limitations. Mix the appropriate amount of drug with a small amount of the usual food; dry dog food may require slight moistening to facilitate mixing. Medicated food must be fully consumed.
(3) Zoo and wildlife animals —(i) Amount. 10 mg/kg per day for 3 days.
(ii) Indications for use. For control of internal parasites of Felidae and Ursidae as follows:
(A) Lion ( Panthera leo ) and Tiger ( Panthera tigris ): Ascarid ( Toxocara cati, Toxascaris leonina ), Hookworm ( Ancylostoma spp.).
(B) Cheetah ( Acinonyx jubatus ): Ascarid ( Toxocara cati, Toxascaris leonina ).
(C) Puma ( Felis concolor ), Panther ( Panthera spp.), Leopard ( Panthera pardus ), Jaguar ( Panthera onca ): Ascarid ( Toxocara cati, Toxascaris leonina ), Hookworm ( Ancylostoma spp.), Tapeworm ( Taenia hydatigena, T. krabbei, T. taeniaeformis ).
(D) Black Bear ( Ursus americanus ): Ascarid ( Baylisascaris transfuga, Toxascaris leonina ), Hookworm ( Ancylostoma caninum ), Tapeworm ( Taenia hydatigena, T. krabbei ).
(E) Polar Bear ( Ursus maritimus ) and Grizzly Bear ( Ursus horribilis ): Ascarid ( Baylisascaris transfuga, Toxascaris leonina ).
(iii) Limitations. Top dress or mix with a small portion of food. Must be fully consumed prior to feeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use 14 days before or during the hunting season.
§ 520.905c   Fenbendazole paste.
(a) Specifications. Each gram of paste contains 100 milligrams (mg) fenbendazole (10 percent).
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.275 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use —(1) Horses —(i) Indications for use and amounts. (A) For the treatment and control of large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles, and pinworms ( Oxyuris equi ). For large strongyles, small strongyles, and pinworms, the recommended dose is 5 mg/kg (2.3 mg/lb).
(B) For treatment and control of ascarids ( Parascaris equorum ). For ascarids, the recommended dose is 10 mg/kg (4.6 mg/lb).
(C) For treatment and control of hypobiotic (encysted early third-stage), late third-stage, and fourth-stage cyathostome larvae, as well as fourth-stage Strongylus vulgaris larvae, the recommended dose is 10 mg/kg (4.6 mg/lb) daily for 5 consecutive days.
(D) For the control of arteritis caused by fourth-stage larvae of Strongylus vulgaris in horses.
(E) Fenbendazole paste 10 percent may be used concomitantly with approved forms of trichlorfon for the indications provided in paragraph (e)(1)(i)(A) of this section and for treating infections of stomach bots as provided in § 520.2520.
(ii) Limitations. Do not use in horses intended for human consumption.
(2) Beef and dairy cattle —(i) Amount. Administer orally 2.3 mg/lb (5 mg/kg) body weight.
(ii) Indications for use. For the treatment and control of: Lungworms: Adult ( Dictyocaulus viviparus ); Stomach worms: Adult brown stomach worms ( Ostertagia ostertagi ), adult and fourth-stage larvae barberpole worms ( Haemonchus contortus ), fourth-stage larvae barberpole worms ( H. placei ), and adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei ); Intestinal worms (adult and fourth-stage larvae): Hookworms ( Bunostomum phlebotomum ), thread-necked intestinal worms ( Nematodirus helvetianus ), small intestinal worms ( Cooperia punctata and C. oncophora ), bankrupt worms ( Trichostrongylus colubriformis ), and nodular worms ( Oesophagostomum radiatum ).
(iii) Limitations. Milk taken during treatment and for 96 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves.
§ 520.905d   Fenbendazole powder.
(a) Specifications. Each 2-ounce packet contains 2.27 grams (4 percent) fenbendazole.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.275 of this chapter.
(d) Conditions of use. It is administered to swine as follows:
(1) Amount. 3 milligrams fenbendazole per kilogram body weight per day (1.36 milligrams per pound per day).
(2) Indications for use. For removal and control of large roundworms ( Ascaris suum ); lungworms ( Metastrongylus apri ); nodular worms ( Oesophagostomum dentatum, O. quadrispinulatum ); small stomach worms ( Hyostrongylus rubidus ); whipworms ( Trichuris suis ); and kidneyworms ( Stephanurus dentatus — mature and immature).
(3) Limitations. Thoroughly mix the contents of the packet(s) with swine ration and administer according to label directions. Feed as sole ration for 3 consecutive days. Can be fed to pregnant sows. No prior withdrawal of feed or water is necessary. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.928   Firocoxib tablets.
(a) Specifications. (1) Each chewable tablet contains 57 or 227 milligrams (mg) firocoxib.
(2) Each tablet contains 57 mg firocoxib.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 000010, 013744, 055246, 055529, and 086101 for use of products described in paragraph (a)(1) as in paragraph (c)(1) of this section; and
(2) Nos. 000010 and 055246 for use of the product described in paragraph (a)(2) as in paragraph (c)(2) of this section.
(c) Conditions of use —(1) Dogs —(i) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. Administer approximately 2 hours before soft tissue or orthopedic surgery.
(ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis; and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount. Administer one 57-mg tablet to horses weighing 800 to 1,300 lb once daily for up to 14 days.
(ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.929   Firocoxib solution.
(a) Specifications. Each milliliter of solution contains 9 milligram (mg) firocoxib.
(b) Sponsors. See No. 051072 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 0.1 mg per kilogram (0.045 mg per pound) of body weight once daily for up to 14 days.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.930   Firocoxib paste.
(a) Specifications. Each milligram (mg) of paste contains 0.82 mg firocoxib.
(b) Sponsors. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 0.1 mg per kilogram (0.045 mg per pound) body weight daily for up to 14 days.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.955   Florfenicol.
(a) Specifications. Each milliliter (mL) contains 23 milligrams (mg) florfenicol.
(b) Sponsors. See Nos. 000061, 054925, and 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.283 of this chapter.
(d) Conditions of use in swine —(1) Amount. Administer in drinking water ad libitum at 400 mg per gallon (100 parts per million (ppm)) for 5 consecutive days.
(2) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.
(3) Limitations. Do not slaughter within 16 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.960   Flumethasone.
(a) Specifications. Each tablet contains 0.0625 milligram of flumethasone.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount —(i) Dogs: Administer orally from 0.0625 to 0.25 milligram daily in divided doses.
(ii) Cats: Administer orally from 0.03125 to 0.125 milligram daily in divided doses.
(2) Indications for use —(i) Dogs: It is used for musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, the disc syndrome, and myositis.
(ii) Dogs and cats: It is used in certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.970   Flunixin.
(a) Specifications. (1) Each 10-gram (g) packet of granules contains flunixin meglumine equivalent to 250 milligrams (mg) of flunixin.
(2) Each 30-g syringe of paste contains flunixin meglumine equivalent to 1,500 mg of flunixin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.
(1) No. 000061 for use of products described in paragraph (a).
(2) No. 061133 for use of the product described in paragraph (a)(2).
(c) Conditions of use in horses —(1) Amount. 0.5 mg per pound of body weight per day for up to 5 days.
(2) Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.980   Fluoxetine.
(a) Specifications. Each chewable tablet contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride.
(b) Sponsor. See No. 055246 in § 510.600 of this chapter.
(c) Conditions of use in dogs —(1) Amount. 1 to 2 mg per kilogram body weight once daily.
(2) Indications for use. For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.998   Fluralaner.
(a) Specifications. (1) Each chewable tablet contains 112.5, 250, 500, 1,000, or 1,400 milligrams (mg) fluralaner.
(2) Each chewable tablet contains 45, 100, 200, 400, or 560 mg fluralaner.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally as a single dose with food:
(i) Chewable tablets described in paragraph (a)(1) of this section. Administer every 12 weeks, an appropriate combination of tablets to provide a minimum dose of 11.4 mg per pound (lb) (25 mg per kilogram (kg)) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks.
(ii) Chewable tablets described in paragraph (a)(2) of this section. Administer monthly, an appropriate combination of tablets to provide a minimum dose of 4.5 mg/lb (10 mg/kg) body weight.
(2) Indications for use —(i) Chewable tablets described in paragraph (a)(1) of this section. Kills adult fleas; for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations ( Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater; and for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater.
(ii) Chewable tablets described in paragraph (a)(2) of this section. Kills adult fleas; for the treatment and prevention of flea infestations ( C. felis ), and the treatment and control of tick infestations ( I. scapularis (black-legged tick), D. variabilis (American dog tick), R. sanguineus (brown dog tick), and H. longicornis (Asian longhorned tick)) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 4.4 lb or greater; and for the treatment and control of A. americanum (lone star tick) infestations for 1 month in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1010   Furosemide.
(a) Specifications. (1) Each tablet contains 12.5 or 50 milligrams (mg) furosemide.
(2) Each bolus contains 2 grams (g) furosemide.
(3) Each packet of powder contains 2 g furosemide.
(4) Each milliliter of syrup contains 10 mg furosemide.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use of dosage forms and strengths listed in paragraph (a) of this section for uses as in paragraph (d) of this section.
(1) No. 000010 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section.
(2) No. 000061 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section; for boluses in paragraph (a)(2) of this section and powder in paragraph (a)(3) of this section for conditions of use in paragraph (d)(1) of this section; and for syrup in paragraph (a)(4) of this section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A).
(3) Nos. 058829 and 069043 for use of syrup in paragraph (a)(4) of this section for conditions of use in paragraph (d)(2)(i) and (d)(2)(ii)(A) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use. It is used as follows:
(1) Cattle —(i) Amount. 1 to 2 mg per pound (/lb) body weight using powder, or one 2-g bolus per animal, per day.
(ii) Indications for use. For treatment of physiological parturient edema of the mammary gland and associated structures.
(iii) Limitations. Treatment not to exceed 48 hours post-parturition. Milk taken during treatment and for 48 hours after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment.
(2) Dogs —(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.
(ii) Indications for use. (A) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
(B) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency.
(3) Cats —(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.
(ii) Indications for use. For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
§ 520.1044   Gentamicin sulfate oral dosage forms.
§ 520.1044a   Gentamicin sulfate oral solution.
(a) Specifications. Each milliliter of aqueous solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.300 of this chapter.
(d) Conditions of use —(1) Amount. Colibacillosis: 1 milliliter per 2 gallons of drinking water for 3 consecutive days, to provide 0.5 milligram/pound/day; swine dysentery: 1 milliliter per 1 gallon of drinking water for 3 consecutive days, to provide 1.0 milligram/pound/day.
(2) Indications for use. In weanling swine for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin, and in swine for control and treatment of swine dysentery associated with Treponema hyodysenteriae.
(3) Limitations. Do not slaughter treated swine for food for at least 3 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1044b   Gentamicin sulfate pig pump oral solution.
(a) Specifications. Each milliliter of pig pump oral solution contains gentamicin sulfate equivalent to 4.35 milligrams of gentamicin.
(b) Sponsor. See Nos. 000061 and 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.300 of this chapter.
(d) Conditions of use —(1) Amount. Administer 1.15 milliliters of pig pump oral solution (5 milligrams of gentamicin) orally per pig one time.
(2) Indications for use. In neonatal swine 1 to 3 days of age for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin.
(3) Limitations. For use in neonatal swine only. Do not slaughter treated swine for food for at least 14 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1044c   Gentamicin sulfate powder.
(a) Specifications. Each gram of powder contains gentamicin sulfate equivalent to:
(1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin.
(2) 333.3 mg gentamicin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section as follows:
(1) No. 000061 for products described in paragraph (a)(1) of this section.
(2) Nos. 016592 and 061133 for product described in paragraph (a)(2) of this section.
(c) Related tolerances. See § 556.300 of this chapter.
(d) Conditions of use in swine —(1) Amount. Administer in drinking water for 3 consecutive days as follows:
(i) For colibacillosis: Gentamicin sulfate equivalent to 25 mg of gentamicin per gallon of drinking water to provide 0.5 mg per pound of body weight per day;
(ii) For swine dysentery: Gentamicin sulfate equivalent to 50 mg of gentamicin per gallon of drinking water to provide 1 mg per pound of body weight per day. Treatment may be repeated if dysentery recurs.
(2) Indications for use. For control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin, and for control and treatment of swine dysentery associated with Brachyspira hyodysenteriae.
(3) Limitations. Withdrawal period: 10 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1060   Glucose and glycine.
(a) Specifications. Each packet of powder contains 8.82 grams sodium chloride, 4.20 grams potassium phosphate, 0.5 gram citric acid anhydrous, 0.12 gram potassium citrate, 6.36 grams aminoacetic acid (glycine), and 44.0 grams glucose.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in calves —(1) Amount. Dissolve each packet in 2 quarts of warm water and administer to each calf as follows:
(i) Scouring and/or dehydrated calves. Feed 2 quarts of solution, twice daily for 2 days (four feedings). No milk or milk replacer should be fed during this period. For the next four feedings (days 3 and 4), use 1 quart of solution together with 1 quart of milk replacer. Thereafter, feed as normal.
(ii) Newly purchased calves. Feed 2 quarts of solution instead of milk as the first feed upon arrival. For the next scheduled feeding, use 1 quart of solution mixed together with 1 quart of milk or milk replacer. Thereafter, feed as normal.
(2) Indications for use. For control of dehydration associated with diarrhea (scours); and as an early treatment at the first signs of scouring. It may also be used as followup treatment following intravenous fluid therapy.
(3) Limitations. The product should not be used in animals with severe dehydration (down, comatose, or in a state of shock). Such animals need intravenous therapy. A veterinarian should be consulted in severely scouring calves. The product is not nutritionally complete if administered by itself for long periods of time. It should not be administered beyond the recommended treatment period without the addition of milk or milk replacer.
§ 520.1084   Grapiprant.
(a) Specifications. Each tablet contains 20, 60, or 100 milligrams (mg) grapiprant.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 0.9 mg/lb (2 mg/kg) once daily by mouth.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1100   Griseofulvin.
(a) Specifications. (1) The powder complies with U.S.P. for griseofulvin, microsize.
(2) Each bolus contains 2.5 grams griseofulvin.
(3) Each tablet contains 125 or 500 milligrams griseofulvin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter.
(1) No. 000061 for use of products described in paragraph (a) for use as in paragraph (d) of this section.
(2) No. 061133 for use of the powder described in paragraph (a)(1) for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Horses —(i) Amount and indications for use. (A) For equine ringworm infection caused by Trichophyton equinum or Microsporum gypseum , administer soluble powder described in paragraph (a)(1) of this section daily as a drench or as a top dressing on feed for not less than 10 days as follows: adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams.
(B) For treating ringworm infection caused by T. equinum , administer boluses described in paragraph (a)(2) of this section daily for not less than 10 days as follows: adults, 1 bolus; yearlings, one-half to 1 bolus; and foals, one-half bolus.
(ii) Limitations. Do not use in horses intended for human consumption.
(2) Dogs and cats: (i) Amount. 125- and 500-milligram tablets administered orally as follows:
(A) Daily (single or divided) dose as follows: For animals weighing up to 6 pounds: 62.5 milligrams; for animals weighing 6 to 18 pounds: 125 milligrams; for animals weighing 18 to 36 pounds: 250 milligrams; for animals weighing 36 to 48 pounds: 375 milligrams; for animal weighing 48 to 75 pounds: 500 milligrams.
(B) Weekly (single) dose: If experience indicates that treatment is more effective for the drug given in large doses, administer at intervals of 7 to 10 days, a dose equal to 10 milligrams/pound of body weight × body weight × number of days between treatments. Dosage should be adjusted according to response. Administer additional dose after the animal is free of infection.
(ii) Indications for use. For treatment of fungal infections of the skin, hair, and claws caused by Trichophyton mentagrophytes, T. rubrum, T. schoenleini, T. sulphurem, T. verrucosum, T. interdigitale, Epidermophyton floccosum, Microsporum gypseum, M. canis, M. audouini.
§ 520.1120   Haloxon oral dosage forms.
§ 520.1120a   Haloxon drench.
(a) Specifications. Each packet contains 141.5 grams haloxon.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Special considerations. Do not use any drug, insecticide, pesticide, or other chemical having cholinesterase-inhibiting activity either simultaneously or within a few days before or after treatment with haloxon.
(d) Related tolerances. See § 556.310 of this chapter.
(e) Conditions of use in cattle —(1) Amount. Dissolve each packet in 32 fluid ounces of water and administer as follows: For animals weighing up to 100 pounds: 1/2 fluid ounce; for animals weighing 100 to 150 pounds: 3/4 fluid ounce; for animals weighing 150 to 200 pounds: 1 fluid ounce; for animals weighing 200 to 300 pounds: 1 1/2 fluid ounces; for animals weighing 300 to 450 pounds: 2 fluid ounces; for animals weighing 450 to 700 pounds: 3 fluid ounces; for animals weighing 700 to 1,000 pounds: 4 fluid ounces; for animals weighing 1,000 to 1,200 pounds: 5 fluid ounces; for animals weighing over 1,200 pounds: 6 fluid ounces. Retreat in 3 to 4 weeks.
(2) Indications for use. For control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia.
(3) Limitations. Do not treat dairy animals of breeding age. Do not treat within 1 week of slaughter.
§ 520.1120b   Haloxon boluses.
(a) Specifications. Each bolus contains 10.1 grams of haloxon.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.310 of this chapter.
(d) Conditions of use in cattle —(1) Amount. Administered one bolus per 500 pounds body weight (35 to 50 milligrams per kilogram of body weight). Retreat in 3 to 4 weeks.
(2) Indications for use. For control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia.
(3) Limitations. Do not treat dairy animals of breeding age or older. Do not treat within 1 week of slaughter.
§ 520.1136   Ilunocitinib.
(a) Specifications. Each tablet contains 4.8, 6.4, 8.5, and 15 milligrams (mg) ilunocitinib.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer orally 0.27 to 0.36 mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once daily, with or without food.
(2) Indications for use. For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1150   Imepitoin.
(a) Specifications. Each tablet contains 100 or 400 milligrams (mg) imepitoin.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer orally twice daily, approximately 12 hours apart, at a dose of 13.6 mg per pound (30 mg/kg) of body weight. Initiate therapy starting 2 days prior to the day of the expected noise event and continuing through the noise event.
(2) Indications for use. For the treatment of noise aversion in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1156   Imidacloprid.
(a) Specifications. Each chewable tablet contains 7.5 or 37.5 milligrams (mg) imidacloprid.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer daily one 7.5-mg chewable tablet to dogs weighing 4 to 22 pounds (lb) or one 37.5-mg chewable table to dogs weighing 23 to 110 lb.
(2) Indications for use. Kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 lb or greater.
(3) Limitations. Do not give to puppies younger than 10 weeks of age or to dogs weighing less than 4 lb. Do not give more than one tablet a day.
§ 520.1157   Iodinated casein.
(a) Specifications. Each 1-gram tablet contains 25 milligrams of iodinated casein.
(b) Sponsor. See No. 017762 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. 1/5 to 1 tablet per 10 pounds of body weight (equivalent to 0.5 to 2.5 milligrams of iodinated casein per pound of body weight).
(2) Indications for use. For dogs for apparent decreased thyroid activity where the signs are alopecia, scaliness of the skin surface, loss of hair, seborrhea, thickening of the skin, hyperpigmentation, and lethargy.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1158   Iodochlorhydroxyquin.
(a) Specifications. Each bolus contains 10 grams of iodochlorhydroxyquin.
(b) Sponsor. See No. 054771 in § 510.600 (c) of this chapter.
(c) Conditions of use —(1) Amount. 1 bolus (10 grams) daily for a 1,000-pound horse.
(2) Indications for use. For treatment of equine diarrhea.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1189   Itraconazole.
(a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) of itraconazole.
(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer 5 mg/kilogram (kg) (0.5 mL/kg) of body weight once daily on alternating weeks for 3 treatment cycles.
(2) Indications for use. For the treatment of dermatophytosis caused by Microsporum canis in cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1192   Ivermectin paste.
(a) Specifications. Each milligram (mg) of paste contains 0.0187 mg (1.87 percent) or 0.00153 mg (0.153 percent) of ivermectin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section:
(1) No. 000010 for use of a 1.87 percent paste as in (e)(1) of this section and a 0.153 percent paste for use as in paragraph (e)(2) of this section.
(2) Nos. 051311, 054925, 058198, and 061133 for use of a 1.87 percent paste for use as in paragraph (e)(1) of this section.
(c) Related tolerances. See § 556.344 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use —(1) Horses —(i) Amount. 200 micrograms per kilogram (91 micrograms per pound) of body weight.
(ii) Indications for use. For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus , Triodontophorus spp. Including T. brevicauda and T. serratus , and Craterostomum acuticaudatum ; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. Including C. coronatus , C. labiatus , and C. labratus , Cyathostomum spp. Including C. catinatum and C. pateratum , Cylicocyclus spp. Including C. insigne , C. leptostomum , C. nassatus , and C. brevicapsulatus , Cylicodontophorus spp., Cylicostephanus spp. Including C. calicatus , C. goldi , C. longibursatus , and C. minutus , and Petrovinema poculatum ; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth-stage larvae): Oxyuris equi ; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum ; Hairworms (adults): Trichostrongylus axei ; Large mouth Stomach Worms (adults): Habronema muscae ; Bots (oral and gastric stages): Gasterophilus spp. Including G. intestinalis and G. nasalis ; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi ; Intestinal Threadworms (adults): Strongyloides westeri ; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
(iii) Limitations. For oral use only. Do not use in horses intended for human consumption.
(2) Cattle —(i) Amount. 23 milligrams per 250 pounds of body weight.
(ii) Indications for use. It is used in cattle for the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) ( Ostertagia ostertagi (including inhibited forms), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, Nematodirus helvetianus, Bunostomum phlebotomum, Strongyloides papillosus (adults only), Oesophagostomum radiatum, Trichuris ovis (adults only)); lungworms (adults and fourth-stage larvae) ( Dictyocaulus viviparus ); grubs (first, second, and third instars) ( Hypoderma bovis, H. lineatum ); and sucking lice ( Linognathus vituli, Haematopinus eurysternus ).
(iii) Limitations. For oral use only. Do not treat cattle within 24 days of slaughter. Because withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age.
§ 520.1193   Ivermectin tablets and chewables.
(a) Specifications. (1) Each tablet or chewable contains 68, 136, or 272 micrograms (mcg) ivermectin.
(2) Each chewable contains 55 or 165 mcg ivermectin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 000010 for use of tablets or chewables described in paragraph (a)(1) as in paragraph (d)(1) and chewables described in paragraph (a)(2) as in paragraph (d)(2) of this section.
(2) Nos. 051311 and 069043 for use of tablets described in paragraph (a)(1) as in paragraph (d)(1) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Dogs. For use in dogs 6 weeks of age and older as follows:
(i) Amount. 6.0 mcg per kilogram (kg) of body weight (2.72 mcg per pound (lb)), minimum. Up to 25 lb, 68 mcg; 26 to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; over 100 lb, a combination of the appropriate tablets. Administer at monthly dosing intervals.
(ii) Indications for use. To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for 1 month (30 days) after infection.
(2) Cats. For use in cats 6 weeks of age and older as follows:
(i) Amount. Up to 2.3 kilograms (up to 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to 15 lb), 165 mcg; over 6.8 kilograms (15 lb), a combination of the appropriate chewables (recommended minimum dose of 24 mcg/kg of body weight (10.9 mcg/lb)). Administer once a month.
(ii) Indications for use. To prevent feline heartworm disease by eliminating the tissue stage of heartworm larvae Dirofilaria immitis for a month (30 days) after infection, and for removal and control of adult and immature (L4) hookworms Ancylostoma tubaeforme and A. braziliense.
§ 520.1194   Ivermectin meal.
(a) Specifications. Each gram of meal contains 6 milligrams ivermectin (0.6 percent).
(b) Sponsor. See No. 017135 in § 510.600(c) of this chapter.
(c) Special considerations. See § 500.25 of this chapter.
(d) Conditions of use in horses —(1) Amount. Administer 136 micrograms (mcg) ivermectin per pound (/lb) body weight (300 mcg/kilogram) as a single dose on approximately 2 lb grain or sweet feed.
(2) Indications for use. For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus , Triodontophorus spp. Including T. brevicauda and T. serratus , and Craterostomum acuticaudatum ; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. Including C. coronatus , C. labiatus , and C. labratus , Cyathostomum spp. Including C. catinatum and C. pateratum , Cylicocyclus spp. Including C. insigne , C. leptostomum , C. nassatus , and C. brevicapsulatus , Cylicodontophorus spp., Cylicostephanus spp. Including C. calicatus , C. goldi , C. longibursatus , and C. minutus , and Petrovinema poculatum ; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi ; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum ; Hairworms (adults): Trichostrongylus axei ; Large Mouth Stomach Worms (adults): Habronema muscae ; Bots (oral and gastric stages): G asterophilus spp. Including G. intestinalis and G. nasalis ; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi ; Intestinal Threadworms (adults): Strongyloides westeri ; Summer Sores caused by Habronema and Draschia spp. Cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Limitations. Do not use in horses intended for human consumption.
§ 520.1195   Ivermectin liquid.
(a) Specifications. (1) Each milliliter (mL) contains 10 milligrams (mg) ivermectin.
(2) Each mL of micellar solution contains 0.8 mg ivermectin.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) Nos. 058005 and 058198 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
(2) No. 058829 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section.
(3) Nos. 000010 and 058829 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.
(c) Related tolerances. See § 556.344 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use —(1) Horses —(i) Amount. 200 micrograms (mcg) per kilogram (/kg) of body weight as a single dose by stomach tube or as an oral drench.
(ii) Indications for use. For treatment and control of:
(A) Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus , Triodontophorus spp. Including T. brevicauda and T. serratus , and Craterostomum acuticaudatum ; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. Including C. coronatus , C. labiatus , and C. labratus , Cyathostomum spp. Including C. catinatum and C. pateratum , Cylicocyclus spp. Including C. insigne , C. leptostomum , C. nassatus , and C. brevicapsulatus , Cylicodontophorus spp., Cylicostephanus spp. Including C. calicatus , C. goldi , C. longibursatus , and C. minutus , and Petrovinema poculatum ; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi ; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum ; Hairworms (adults): Trichostrongylus axei ; Large mouth Stomach Worms (adults): Habronema muscae ; Bots (oral and gastric stages): Gasterophilus spp. Including G. intestinalis and G. nasalis ; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi ; Intestinal Threadworms (adults), Strongyloides westeri ; Summer Sores caused by Habronema and Draschia spp. Cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
(B) Large Strongyles ( Strongylus equinus (adult), S. vulgaris (adult and arterial larval stages), S. endentatus (adult and migrating tissue stages), Triodontophorus spp. (adult)); Small Strongyles including those resistant to some benzimidazole class compounds ( Cyathostomum spp. (adult and fourth-stage larvae), Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp.); Pinworms ( Oxyuris equi (adult and fourth-stage larvae)); Ascarids ( Parascaris equorum (adult and third- and fourth-stage larvae)); Hairworms ( Trichostongylus axei ( adult)); Large mouth Stomach Worms ( Habronema muscae (adult)); Stomach Bots ( Gastrophilus spp. (oral and gastric stages)); Lungworms ( Dictyocaulus arnfieldi (adult and fourth-stage larvae)); intestinal threadworms ( Strongyloides westeri (adult)); Summer Sores caused by Habronema and Draschia spp. Cutaneous third-stage larvae; and Dermatitis caused by neck threadworm microfilariae ( Onchocerca spp.).
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Sheep —(i) Amount. 200 mcg/kg (3 mL/26 pounds) of body weight as a single dose oral drench.
(ii) Indications for use. For treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms ( Haemonchus contortus, H. placei (adults only), Ostertagia circumcincta, Trichostrongylus axei, T. colubriformis, Cooperia oncophora (adults only), C. curticei, Oesophagostomum columbianum, O. venulosum (adults only), Nematodirus battus, N. spathiger, S. papillosus (adults only), Chabertia ovina (adult only), Trichuris ovis (adults only)); lungworms ( D. filaria ); and all larval stages of the nasal bot Oestrus ovis.
(iii) Limitations. For use in sheep only. Do not use in other animal species as severe adverse reactions, including fatalities in dogs, may result. Do not treat sheep within 11 days of slaughter.
§ 520.1196   Ivermectin and pyrantel tablets.
(a) Specifications. Each chewable tablet contains either 68 micrograms (µg) of ivermectin and 57 milligrams (mg) of pyrantel (as pamoate salt), or 136 µg and 114 mg, or 272 µg and 227 mg, respectively.
(b) Sponsors. See Nos. 000010, 051311, and 053701 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer a minimum of 6 µg of ivermectin and 5 mg of pyrantel per kilogram (2.72 µg and 2.27 mg per pound) of body weight monthly.
(ii) Indications for use. To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for up to a month (30 days) after infection and treatment and control of adult roundworms Toxocara canis and Toxascaris leonina, and adult hookworms Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 520.1197   Ivermectin sustained-release bolus.
(a) Specifications. Each sustained-release bolus contains 1.72 grams of ivermectin.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.344 of this chapter.
(d) Conditions of use in ruminating calves —(1) Amount. Administer one bolus per calf weighing at least 275 pounds (lb) (125 kilograms (kg)) and not more than 660 lb (300 kg) on the day of administration.
(2) Indications. For treatment and control, throughout the grazing season (approximately 130 days), of gastrointestinal roundworms Haemonchus placei, Ostertagia ostertagi (including inhibited fourth-stage larvae), Trichostrongylus axei, T. colubriformis, Cooperia spp., Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum radiatum; lungworms Dictyocaulus viviparus; grubs Hypoderma spp.; sucking lice Linognathus vituli, Solenopotes capillatus; mange mites Psoroptes ovis, Sarcoptes scabiei, and ticks Amblyomma americanum.
(3) Limitations. The bolus was specifically designed for use in cattle; do not use in other animal species. Calves must be ruminating and older than 12 weeks of age. Do not administer to calves weighing less than 275 lb (125 kg). Do not administer a damaged bolus. Because a milk withdrawal time has not been established, do not use in female dairy cattle of breeding age. Do not slaughter cattle within 180 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1198   Ivermectin and praziquantel paste.
(a) Specifications. Each milligram (mg) of paste contains:
(1) 0.0155 mg (1.55 percent) ivermectin and 0.0775 mg (7.75 percent) praziquantel.
(2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 percent) praziquantel.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.—
(1) No. 000010 for use of product described in paragraph (a)(1) of this section as in paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) of this section.
(2) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii), (d)(2)(ii), and (d)(3) of this section.
(c) Special considerations. See § 500.25 of this chapter.
(d) Conditions of use in horses —(1) Amount. (i) 200 micrograms (mcg) per kilogram (/kg) ivermectin (91 mcg per pound (/lb)) and 1 mg/kg praziquantel (454 mcg/lb) body weight.
(ii) 200 mcg/kg ivermectin (91 mcg/lb) and 1.5 mg/kg praziquantel (681 mcg/lb) body weight.
(iii) 200 mcg/kg ivermectin (91 mcg/lb) and 2.5 mg/kg praziquantel (1.14 mg/lb).
(2) Indications for use. (i) For treatment and control of the following parasites: Tapeworms— Anoplocephala perfoliata; Large Strongyles (adults)— Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. Including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)— Coronocyclus spp. Including C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp. Including C. catinatum and C. pateratum; Cylicocyclus spp. Including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. Including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)— Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)— Parascaris equorum; Hairworms (adults)— Trichostrongylus axei; Large-mouth Stomach Worms (adults)— Habronema muscae; Bots (oral and gastric stages)— Gasterophilus spp. Including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae)— Dictyocaulus arnfieldi; Intestinal Threadworms (adults)— Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. Cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae of Onchocerca sp.
(ii) For treatment and control of the following parasites: Tapeworms— Anoplocephala perfoliata; Large Strongyles (adults)— Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp.; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)— Cyathostomum spp.; Cylicocyclus spp.; Cylicostephanus spp., Cylicodontophorus spp.; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)— Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)— Parascaris equorum; Hairworms (adults)— Trichostrongylus axei; Large-mouth Stomach Worms (adults)— Habronema muscae; Bots (oral and gastric stages)— Gasterophilus spp.; Lungworms (adults and fourth-stage larvae)— Dictyocaulus arnfieldi; Intestinal Threadworms (adults)— Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. Cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
(iii) For treatment and control of the following parasites in horses over 5 months of age: Tapeworms— Anoplocephala perfoliata; Large Strongyles (adults)— Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. Including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)— Coronocyclus spp. Including C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp. Including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)— Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)— Parascaris equorum; Hairworms (adults)— Trichostrongylus axei; Large-mouth Stomach Worms (adults)— Habronema muscae; Bots (oral and gastric stages)— Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae)— Dictyocaulus arnfieldi; Intestinal Threadworms (adults)— Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae of Onchocerca sp.
(3) Limitations. For oral use only. Do not use in horses intended for human consumption.
§ 520.1199   Ivermectin, pyrantel, and praziquantel tablets.
(a) Specifications. Each chewable tablet or soft chewable tablet contains:
(1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel;
(2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel;
(3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or
(4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.
(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer monthly according to body weight as follows:
(i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this section.
(ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of this section.
(iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of this section.
(iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of this section.
(v) Greater than 100 lb: use the appropriate combination of tablets.
(2) Indications for use. To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for 1 month (30 days) after infection and for the treatment and control of roundworm ( Toxocara canis, Toxascaris leonina ), hookworm ( Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense ) and tapeworm ( Dipylidium caninum, Taenia pisiformis ) infections.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1200   Ivermectin, fenbendazole, and praziquantel tablets.
(a) Specifications. Each chewable tablet contains either:
(1) 68 micrograms (µg) ivermectin, 1.134 grams fenbendazole, and 57 milligrams (mg) praziquantel; or
(2) 27 µg ivermectin, 454 mg fenbendazole, and 23 mg praziquantel.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer tablets to provide 6 µg per kilogram (/kg) ivermectin, 100 mg/kg fenbendazole, and 5 mg/kg praziquantel.
(2) Indications for use. For the treatment and control of adult Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the prevention of heartworm disease caused by Dirofilaria immitis in adult dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1204   Kanamycin, bismuth subcarbonate, activatedattapulgite.
(a) Specifications. (1) Each 5 milliliters (mL) of suspension contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite (aluminum magnesium silicate).
(2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 5 mL of suspension or 1 tablet per 20 pounds body weight every 8 hours. Maximum dose: 5 mL of suspension or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of suspension or 1/2 tablet every 8 hours. A recommended initial loading dose should be twice the amount of a single dose.
(2) Indications for use. For the treatment of bacterial enteritis caused by organisms susceptible to kanamycin and the symptomatic relief of the associated diarrhea.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1242   Levamisole.
§ 520.1242a   Levamisole powder.
(a) Specifications. Each package of powder contains 9.075, 11.7, 18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) for use as follows:
(1) No. 000061 for use of 46.8- and 544.5-g packages as in paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section; for 11.7-, 46.8-, and 544.5-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for an 18.15-g package as in paragraph (e)(3) of this section.
(2) No. 054771 for use of a 46.8-g package as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section; for 11.7- and 46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section; and for 9.075- and 18.15-g packages as in paragraph (e)(3) of this section.
(3) No. 016592 for use of 46.8- and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) and (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section.
(4) No. 061133 for use of 46.8-, 362.7-, and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 18.15-g package as in paragraph (e)(3) of this section.
(c) Related tolerances. See § 556.350 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use. It is used as an anthelmintic as follows:
(1) Cattle —(i) Amount. 8 milligrams per kilogram (mg/kg) body weight as a drench.
(ii) Indications for use. (A) Effective against the following nematode infections: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ); intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ); and lungworms ( Dictyocaulus ).
(B) Effective against the following adult nematode infections: Stomach worms ( Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei ); intestinal worms ( T. longispicularis, Cooperia oncophora, C. punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum ); and lungworms ( Dictyocaulus viviparus ).
(iii) Limitations. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult your veterinarian before using in severely debilitated animals.
(2) Sheep —(i) Amount. 8 mg/kg body weight as a drench.
(ii) Indications for use. (A) Effective against the following nematode infections: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ); intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia ); and lungworms ( Dictyocaulus ).
(B) Effective against the following adult nematode infections: Stomach worms ( Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta ); intestinal worms ( Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina ), and lungworms ( Dictyocaulus filaria ).
(iii) Limitations. Do not slaughter for food within 72 hours of treatment. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult veterinarian before using in severely debilitated animals.
(3) Swine —(i) Amount. 8 mg/kg body weight in drinking water.
(ii) Indications for use. Effective against the following nematode infections: Large roundworms ( Ascaris suum ), nodular worms ( Oesophagostomum spp.), intestinal thread worms ( Strongyloides ransomi ) and lungworms ( Metastrongylus spp. ).
(iii) Limitations. Do not administer within 72 hours of slaughter for food. Pigs maintained under conditions of constant exposure to worms may require retreatment within 4 to 5 weeks after the first treatment. Consult your veterinarian before administering to sick swine.
§ 520.1242b   Levamisol boluses or oblets.
(a) Specifications. Each bolus contains 2.19 grams levamisol hydrochloride. Each oblet contains 0.184 grams levamisol hydrochloride.
(b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
(c) Required labeling. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
(d) Related tolerances. See § 556.350 of this chapter.
(e) Conditions of use —(1) Cattle —(i) Amount. Administer orally 2.19-gram boluses as a single dose as follows: 250 to 450 pounds, 1/2 bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, 1 1/2 boluses.
(ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ), and lungworms ( Dictyocaulus ).
(iii) Limitations. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Consult veterinarian before using in severely debilitated animals.
(2) Sheep —(i) Amount. Administer orally one 0.184-gram oblet for each 50 pounds of body weight.
(ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia ), and lungworms ( Dictyocaulus ).
(iii) Limitations. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 72 hours of treatment. Consult a veterinarian before using in severely debilitated animals.
§ 520.1242c   Levamisol and piperazine.
(a) Specifications. (1) Each ounce of solution contains 0.36 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 3.98 grams of piperazine base.
(2) A soluble powder which when constituted with water contains in each fluid ounce 0.45 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 5.0 grams of piperazine base.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Aqueous solution: administer by stomach tube or drench 1 fluid ounce per 100 pounds of body weight. Reconstituted soluble powder: administer by stomach tube 1 fluid ounce per 125 pounds of body weight. If reinfection occurs, re-treat animals at 6- to 8-week intervals.
(2) Indications for use. An anthelmintic effective against infections of large strongyles ( Strongylus vulgaris, S. edentatus ), small strongyles ( Cylicocercus spp., Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp.), ascarids ( Parascaris equorum ), and pinworms ( Oxyuris equi ).
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1242d   Levamisole resinate.
(a) Specifications. The drug is levamisole adsorbed on a resin, in a concentration equivalent to 10 percent levamisole hydrochloride. Each 2.05-ounce (58.1 gram) packet contains levamisole equivalent to 5.806 grams of levamisole hydrochloride.
(b) Sponsor. See No. 043781 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.350 of this chapter.
(d) Conditions of use. In swine it is used as follows:
(1) Amount. The equivalent of 8 milligrams per kilogram of body weight, as a single dose, mixed in the animal's ration.
(2) Indications for use. For the removal of and control of the following nematode infections: large roundworms ( Ascaris suum ), nodular worms ( Oesophagostomum spp.), lungworms ( Metastrongylus spp.), intestinal threadworms ( Strongyloides ransomi ), and swine kidney worms ( Stephanurus dentatum ).
(3) Limitations. For pigs from weaning to market weight, mix one 58.1-gram packet of levamisole resinate containing the equivalent of 10-percent levamisole hydrochloride in 40 pounds of feed and administer 1 pound of medicated feed per 40 pounds of body weight as sole ration. For breeding swine, mix 1 packet of the 10-percent resinate in 16 pounds of feed and administer 1 pound of medicated feed per 100 pounds of body weight as sole ration. Administer as single doses. Withhold regular feed overnight and administer medicated feed the following morning. Do not withhold water during fasting. Do not treat within 72 hours of slaughter. Salivation or muzzle foam may be observed. The reaction will disappear a short time after feeding. If pigs are infected with mature lungworms, coughing and vomiting may be observed. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1242e   Levamisole hydrochloride effervescent tablets.
(a) Specifications. Each tablet contains 907 milligrams of levamisole hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.350 of this chapter.
(d) Conditions of use. It is used for swine as follows:
(1) Amount. The equivalent of 8 milligrams of levamisole hydrochloride per kilogram of body weight, as a single dose.
(2) Indications for use. See § 520.1242a(f)(3)(ii).
(3) Limitations. Withholding water from pigs before treatment is not necessary. Add one tablet for each 2 1/2 gallons of water; mix thoroughly. Allow 1 gallon of medicated water for each 100 pounds body weight of pigs to be treated. No other source of water should be offered. After pigs have consumed medicated water, resume use of regular water. Pigs maintained under conditions of constant worm exposure may require re-treatment within 4 to 5 weeks. Consult your veterinarian before administering to sick swine. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not administer within 72 hours of slaughter for food.
§ 520.1242f   Levamisol gel.
(a) Specifications. Each gram of gel contains 115 milligrams (11.5 percent) levamisol hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.350 of this chapter.
(d) Conditions of use —(1) Cattle —(i) Amount. Eight milligrams of levamisole hydrochloride per kilogram of body weight, as a single oral dose.
(ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ), and lungworms ( Dictyocaulus ).
(iii) Limitations. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment; do not administer to cattle within 6 days of slaughter for food; do not administer to dairy animals of breeding age; consult veterinarian before using in severely debilitated animals.
(2) Breeding swine —(i) Amount. Eight milligrams per kilogram of body weight (3.6 milligrams per pound) as a single oral dose.
(ii) Conditions of use. For treating breeding swine infected with the following nematodes: Large roundworms ( Ascaris suum ), nodular worms ( Oesophagostomum spp.), lungworms ( Metastrongylus spp.), intestinal threadworms ( Strongyloides ransomi ), and kidney worms ( Stephanurus dentatus ).
(iii) Limitations. May require retreatment in 4 to 5 weeks. Do not use within 11 days of slaughter for food. Consult your veterinarian for assistance before using in severely debilitated animals and in the diagnosis, treatment, and control of parasitism.
§ 520.1242g   Levamisole resinate and famphur paste.
(a) Specifications. The drug is a paste containing 11.6 percent levamisole resinate (50 percent potency) and 23.6 percent famphur.
(b) Sponsor. See 000061 in § 510.600(c) of this chapter.
(c) Special considerations. Do not use any cholinesterase-inhibiting drugs, pesticides, insecticides, or chemicals on cattle simultaneously or within a few days before or after treatment with this product.
(d) Related tolerances. See §§ 556.273 and 556.350 of this chapter.
(e) Conditions of use in cattle —(1) Amount. 8 milligrams of levamisole hydrochloride (equivalent) and 30 milligrams of famphur activity per kilogram of body weight.
(2) Indications for use. For treatment of cattle infected with the following parasites: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ), lungworms ( Dictyocaulus ), cattle grubs ( Hypoderma ), biting lice ( Bovicola ), and sucking lice ( Linognathus, Solenoptes ).
(3) Limitations. Drug is not effective against lice eggs. Conditions of constant helminth and ectoparasitic exposure may require retreatment within 2 to 4 weeks after first treatment. Do not administer to cattle within 19 days of slaughter. Do not administer to dairy animals of breeding age. Do not use in calves less than 3 months old, or in debilitated animals. Do not treat Brahman bulls. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1248   Levothyroxine.
(a) Specifications. Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.
(b) Sponsors. See Nos. 059051 and 061690 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer by mouth as follows:
(i) No. 061690: 0.1 mg/10 pounds (lb) body weight (0.022 mg/kilogram (kg)) as a single dose every 24 hours or as a divided dose every 12 hours.
(ii) No. 059051: 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily.
(2) Indications for use. For replacement therapy for diminished thyroid function in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1263   Lincomycin.
§ 520.1263a   Lincomycin tablets and syrup.
(a) Specifications. (1) Each ounce of syrup contains lincomycin hydrochloride equivalent to either 25 or 50 milligrams (mg) lincomycin.
(2) Each tablet contains lincomycin hydrochloride equivalent to either 25 or 50 mg lincomycin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer orally 10 mg per pound of body weight every 12 hours, or 7 mg per pound of body weight every 8 hours, for up to 12 days.
(2) Indications for use. For infections caused by gram-positive organisms which are sensitive to its action, particularly streptococci and staphylococci.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1263b   Lincomycin powder.
(a) Specifications. Each gram of soluble powder contains lincomycin hydrochloride equivalent to 0.4 grams of lincomycin.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) Nos. 054771 and 061133 for use as in paragraph (d) of this section.
(2) Nos. 016592 and 076475 for use as in paragraphs (d)(1) and (2) of this section.
(c) Tolerances. See § 556.360 of this chapter.
(d) Conditions of use —(1) Swine —(i) Amount. 250 milligrams per gallon of drinking water to provide 3.8 milligrams per pound of body weight per day.
(ii) Indications for use. For the treatment of swine dysentery (bloody scours).
(iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Do not use for more than 10 days. If clinical signs of disease have not improved within 6 days, discontinue treatment and reevaluate diagnosis. The safety of lincomycin has not been demonstrated in pregnant swine or swine intended for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Chickens —(i) Amount. 64 milligrams per gallon of drinking water.
(ii) Indications for use. For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin in broiler chickens.
(iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Administer for 7 consecutive days. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Not for use in layer and breeder chickens. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Honey bees —(i) Amount. Mix 100 milligrams lincomycin with 20 grams confectioners'/powdered sugar and dust over the top bars of the brood chamber once weekly for 3 weeks.
(ii) Indications for use. For the control of American foulbrood ( Paenibacillus larvae ).
(iii) Limitations. The drug should be fed early in the spring or late in the fall and consumed by the bees before the main honey flow begins to avoid contamination of production honey. Complete treatments at least 4 weeks before main honey flow. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1265   Lincomycin and spectinomycin powder.
(a) Specifications. The following salts of lincomycin and spectinomycin are present in a soluble powder in the ratio of 1 to 2 on the basis of equivalency of lincomycin base to equivalency of spectinomycin base:
(1) Lincomycin hydrochloride monohydrate and spectinomycin sulfate tetrahydrate.
(2) Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 054771 for use of product described in paragraph (a)(1) of this section.
(2) Nos. 016592, 061133, and 066104 for use of product described in paragraph (a)(2) of this section.
(c) Tolerances. See §§ 556.360 and 556.600 of this chapter.
(d) Conditions of use in chickens —(1) Amount. 2 grams of antibiotic activity per gallon of drinking water; administer as the sole source of water for the first 5 to 7 days of life.
(2) Indications for use. As an aid in the control of airsacculitis caused by either Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1284   Liothyronine.
(a) Specifications. Each tablet contains 60 or 120 micrograms (µg) liothyronine as the sodium salt.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally to dogs at levels up to 12.8 µg per kilogram (/kg) of body weight per day. Dosage should be adjusted according to the severity of the condition and the response of the patient. Dosage at the total replacement level (12.8 µg/kg of body weight) should be considered for initiating therapy and then titrated downward for optimum maintenance effect. Twice daily administration is recommended.
(2) Indications for use. For treatment of hypothyroidism in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1286   Lotilaner.
(a) Specifications. Each chewable tablet contains:
(1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg) lotilaner; or
(2) For use in cats: 12 or 48 mg lotilaner.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).
(ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations ( Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age or older and weighing 4.4 pounds or greater.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. Administer orally once a month at the recommended minimum dosage of 2.7 mg/lb (6 mg/kg).
(ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations ( Ctenocephalides felis ) for 1 month in cats and kittens 8 weeks of age and older, and weighing 2.0 pounds or greater; and for the treatment and control of Ixodes scapularis (black-legged tick) for 1 month in cats and kittens 6 months of age and older, and weighing 2.0 pounds or greater.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1287   Lotilaner, moxidectin, praziquantel, and pyrantel.
(a) Specifications. Each chewable tablet contains:
(1) 56.25 milligrams (mg) lotilaner, 0.056 mg moxidectin, 14.25 mg praziquantel, and 14.25 mg pyrantel (as pamoate salt);
(2) 112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel, and 28.5 mg pyrantel (as pamoate salt);
(3) 225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and 57 mg pyrantel (as pamoate salt);
(4) 450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and 114 mg pyrantel (as pamoate salt); or
(5) 900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and 228 mg pyrantel (as pamoate salt).
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt).
(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina ), hookworm (adult Uncinaria stenocephala ), and tapeworm ( Dipylidium caninum, Taenia pisiformis and Echinococcus granulosus ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations ( Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1288   Lufenuron tablets.
(a) Specifications —(1) Tablets containing 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section.
(2) Flavored tablets containing 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and (c)(1)(iii) of this section.
(3) Flavored tablets containing 90 or 204.9 mg lufenuron for use as in paragraphs (c)(2)(i), (c)(2)(ii)(A) or (c)(2)(ii)(B), and (c)(2)(iii) of this section.
(4) Flavored tablets containing 135 or 270 mg lufenuron for use as in paragraphs (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Minimum of 10 mg lufenuron per kilogram (4.5 mg per pound (lb)) of body weight, once a month.
(ii) Indications for use —(A) For the prevention and control of flea populations.
(B) The concurrent use of flavored lufenuron tablets described in paragraph (a)(2) of this section as in paragraph (c)(1)(ii)(A) of this section with nitenpyram tablets as in § 520.1510(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching.
(iii) Limitations. For use in dogs and puppies 4 weeks of age and older.
(2) Cats —(i) Amount. Minimum of 30 mg lufenuron per kilogram (13.6 mg/lb) of body weight, once a month.
(ii) Indications for use —(A) For the control of flea populations.
(B) The concurrent use of flavored lufenuron tablets described in paragraph (a)(3) of this section as in paragraph (c)(2)(ii)(A) of this section with nitenpyram tablets as in § 520.1510(d)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching.
(iii) Limitations. For use in cats and kittens 4 weeks of age and older.
§ 520.1289   Lufenuron suspension.
(a) Specifications. Each individual dose pack contains either 135 or 270 milligrams of lufenuron.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in cats —(1) Amount. Minimum of 13.6 milligrams per pound of body weight (30 milligrams per kilogram). Recommended dose of 135 milligrams for up to 10 pounds of body weight or 270 milligrams for 11 to 20 pounds. Cats over 20 pounds are provided the appropriate combination of packs.
(2) Indications for use. For control of flea populations.
(3) Limitations. For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation.
§ 520.1310   Marbofloxacin.
(a) Specifications. Each tablet or chewable tablet contains 25, 50, 100, or 200 milligrams (mg) marbofloxacin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section:
(1) Nos. 017033, 054771, and 086117 for use of tablets.
(2) No. 086101 for use of chewable tablets.
(c) [Reserved]
(d) Conditions of use —(1) Amount. 1.25 mg per pound (/lb) of body weight once daily, but may be increased to 2.5 mg/lb of body weight once daily.
(2) Indications for use. For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.
§ 520.1315   Maropitant.
(a) Specifications. Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.
(b) Sponsors. See Nos. 054771, 086101, and 086117 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Indications for use and amount. (i) For prevention of acute vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 consecutive days.
(ii) For prevention of acute vomiting in dogs 7 months of age and older, administer a minimum dose of 2.0 mg/kg body weight once daily until resolution of acute vomiting.
(iii) For prevention of vomiting due to motion sickness in dogs 4 months of age and older, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1320   Mebendazole.
(a) Specifications. (1) Each gram of powder contains either 40 or 166.7 milligrams of mebendazole.
(2) Each gram of paste contains 200 milligrams of mebendazole.
(3) Each milliliter of suspension contains 33.3 milligrams of mebendazole.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Horses —(i) Amount. 1 gram of mebendazole per 250 pounds of body weight per dose, as an oral powder, paste or suspension.
(ii) Indications for use. For treatment of infections caused by large roundworms ( Parascaris equorum ); large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ); small strongyles; and mature and immature (4th larval stage) pinworms ( Oxyuris equi ).
(iii) Limitations. The drug is compatible with carbon disulfide. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs —(i) Amount. Administer 100 milligrams of mebendazole per 10 pounds of body weight, once daily for 3 days, as an oral powder by mixing with a small quantity of food, preferably before the regular meal.
(ii) Indications for use. The drug is used for treatment of infections of roundworms ( Toxocara canis ), hookworms ( Ancylostoma caninum, Uncinaria stenocephala ), whipworms ( Trichuris vulpis ), and tapeworms ( Taenia pisiformis ).
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1326   Mebendazole and trichlorfon oral dosage forms.
§ 520.1326a   Mebendazole and trichlorfon powder.
(a) Specifications. Each gram of powder contains 83.3 milligrams of mebendazole and 375.0 milligrams of trichlorofon.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorofon per kilogram of body weight.
(2) Indications for use. It is used in horses for the treatment of infections of bots ( Gastrophilus intestinalis and G. nasalis ), large roundworms ( Parascaris equorum ), large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles, and pinworms ( Oxyuris equi. )
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1326b   Mebendazole and trichlorfon paste.
(a) Specifications. Each gram of paste contains 100 milligrams of mebendazole and 454 milligrams of trichlorfon.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorfon per kilogram of body weight.
(2) Indications for use. It is used in horses for treatment of infections of bots ( Gastrophilus intestinalis and G. nasalis ), large roundworms ( Parascaris equorum ), large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles, and pinworms ( Oxyuris equi ).
(3) Limitations. Do not administer more than once every 30 days. Do not treat sick or debilitated animals, foals under 4 months of age, or mares in the last month of pregnancy. Trichlorfon is a cholinesterase inhibitor. Do not administer simultaneously or within a few days before or after treatment with, or exposure to, cholinesterase-inhibiting drugs, pesticides, or chemicals. Do not administer intravenous anesthetics, especially muscle relaxants, concurrently. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1330   Meclofenamic acid granules.
(a) Specifications. Each gram of granules contains 5 milligrams (5 percent) meclofenamic acid.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 1 milligram per pound of body weight (1 gram per 1000 pounds) once daily for 5 to 7 days by addition to the daily grain ration.
(2) Indications for use. For the treatment of acute or chronic inflammatory diseases involving the musculoskeletal system.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1331   Meclofenamic acid tablets.
(a) Specifications. Each tablet contains either 10 or 20 milligrams of meclofenamic acid.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 1.1 milligrams per kilogram (0.5 milligram per pound) daily for 5 to 7 days.
(2) Indications for use. For the relief of signs and symptoms of chronic inflammatory disease involving the musculoskeletal system.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1341   Megestrol.
(a) Specifications. Each tablet contains 5 or 20 milligrams of megestrol acetate.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally, intact, or crushed and mixed with food as follows:
(i) For the postponement of estrus by proestrus treatment: 1 milligram per pound of body weight per day for 8 days.
(ii) For the postponement of estrus by anestrus treatment: 0.25 milligram per pound of body weight per day for 32 days.
(iii) For alleviation of false pregnancy: 1 milligram per pound of body weight per day for 8 days.
(2) Indications for use. For the postponement of estrus and the alleviation of false pregnancy in female dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.