Title 21—Food and Drugs--Volume 1
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1367   Meloxicam.
(a) Specifications —(1) Each milliliter of suspension contains 0.5 milligrams (mg) meloxicam.
(2) Each milliliter of suspension contains 1.5 mg meloxicam.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section:
(1) No. 000010 for use of the products described in paragraph (a) of this section; and
(2) Nos. 013744 and 055529 for use of the product described in paragraph (a)(2) of this section.
(c) Conditions of use in dogs —(1) Amount. Administer orally as a single dose at 0.09 mg per pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) on the first day of treatment. For all treatment after day 1, administer 0.045 mg/lb (0.1 mg/kg) body weight once daily.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1375   Methimazole tablets.
(a) Specifications. Each tablet contains 2.5 or 5 milligrams (mg) methimazole.
(b) Sponsor. See No. 043264 in § 510.600 of this chapter.
(c) Conditions of use in cats —(1) Amount. The starting dose is 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 levels and clinical response.
(2) Indications for use. For the treatment of hyperthyroidism.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1376   Methimazole solution.
(a) Specifications. Each milliliter of solution contains 5 milligrams (mg) methimazole.
(b) Sponsor. See No. 055529 in § 510.600(c) of this chapter.
(c) Conditions of use in cats —(1) Amount. Administer a starting dose of 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 (TT4) levels and clinical response. Dose adjustments should be made in 2.5 mg increments with a maximum dosage of 20 mg per day divided, not to exceed 10 mg as a single dose.
(2) Indications for use. For the treatment of hyperthyroidism.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1380   Methocarbamol.
(a) Specifications. Each tablet contains 500 milligrams (mg) of methocarbamol.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer 60 mg per pound of body weight in two or three equally divided doses, followed each following day by 30 to 60 mg per pound of body weight, usually not to exceed 14 to 21 days.
(2) Indications for use. As an adjunct to therapy for acute inflammatory and traumatic conditions of the skeletal muscles in order to reduce muscular spasms.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1408   Methylprednisolone.
(a) Specifications. Each tablet contains 1, 2, or 4 milligrams (mg) of methylprednisolone.
(b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. 5 to 15 pounds (lbs): 2 mg; 15 to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 mg. Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed.
(2) Indications for use. As an anti-inflammatory agent.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1409   Methylprednisolone and aspirin.
(a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Under 15 pounds, 1/4 to 1 tablet daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and over, 2 tablets daily. Administer total daily dose in divided doses 6 to 10 hours apart, with a light feeding. When response is attained, dosage should be gradually reduced until maintenance level is achieved.
(2) Indications for use. As an anti-inflammatory and analgesic agent.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1422   Metoserpate hydrochloride.
(a) Chemical name. Methyl- o -methyl-18-epireserpate hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.410 of this chapter.
(d) Conditions of use. It is used in drinking water for replacement chickens as follows:
(1) Amount. 568.5 milligrams per gallon (0.015 percent).
(i) Indications for use. As a tranquilizer for flock treatment of chickens prior to handling.
(ii) Limitations. To be used one time as a treatment for replacement chickens up to 16 weeks of age; usual drinking water should be withheld prior to treatment to provide adequate consumption of medicated drinking water; not for use in laying chickens; chickens slaughtered within 72 hours following treatment must not be used for food.
(2) Amount. 2 to 4 milligrams per 2.2 pounds of body weight.
(i) Indications for use. As an aid in control of hysteria.
(ii) Limitations. To be used as a treatment for replacement chickens up to 16 weeks of age; usual drinking water should be withheld prior to treatment to provide adequate consumption of medicated drinking water; the drug should be administered at a dosage level of 4 milligrams per 2.2 pounds of body weight followed by 2 treatments at 4-day intervals of 2 milligrams per 2.2 pounds of body weight; not for use in laying chickens; chickens slaughtered within 72 hours following treatment must not be used for food.
§ 520.1425   Metronidazole.
(a) Specifications. Each milliliter of suspension contains 125 milligrams (mg) metronidazole.
(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer 25 mg per kilogram (11.3 mg per pound) of body weight twice daily for 5 consecutive days.
(2) Indications for use. For the treatment of Giardia duodenalis infection in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1430   Mibolerone.
(a) Specifications. Each milliliter contains 100 micrograms of mibolerone.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 30 micrograms for animals weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 micrograms for animals weighing over 100 pounds, German Shepherds, or German Shepherd mix. Administer daily, orally or in a small amount of food, at least 30 days before expected initiation of heat, and continue daily as long as desired, but not for more than 24 months.
(2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1441   Milbemycin.
(a) Specifications. Each flavored tablet contains 2.3, 5.75, 11.5, or 23.0 milligrams (mg) of milbemycin oxime.
(b) Sponsors. See Nos. 013744 and 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. For hookworm, roundworm, and whipworm, administer 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)). For heartworm, administer 0.05 mg/lb of body weight (0.1 mg/kg). Administer once a month.
(ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis, control of hookworm infections caused by Ancylostoma caninum, and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonina and whipworm infections caused by Trichuris vulpis in dogs and puppies 4 weeks of age or greater and 2 pounds body weight 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 0.91 mg/lb of body weight (2.0 mg/kg) once a month.
(ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6 weeks of age or greater and 1.5 pounds body weight or greater.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1443   Milbemycin oxime and lufenuron.
(a) Specifications. (1) Tablets containing: 2.3 milligrams (mg) milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 mg lufenuron.
(2) Flavored tablets containing: 2.3 mg milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 mg lufenuron.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use —(1) Dogs —(i) Amount. 0.5 mg milbemycin oxime and 10 mg lufenuron per kilogram of body weight, once a month.
(ii) Indications for use. (A) For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis, for prevention and control of flea populations, for control of adult Ancylostoma caninum (hookworm), and for removal and control of adult Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis (whipworm) infections.
(B) The concurrent use of flavored milbemycin oxime and lufenuron tablets described in paragraph (a)(2) of this section as in paragraph (d)(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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 520.1445   Milbemycin oxime and praziquantel.
(a) Specifications. Each chewable tablet contains:
(1) 2.3 milligrams (mg) milbemycin oxime and 22.8 mg praziquantel;
(2) 5.75 mg milbemycin oxime and 57 mg praziquantel;
(3) 11.5 mg milbemycin oxime and 114 mg praziquantel; or
(4) 23 mg milbemycin oxime and 228 mg praziquantel.
(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, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel.
(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm ( Toxocara canis, Toxascaris leonina ), adult hookworm ( Ancylostoma caninum ), adult whipworm ( Trichuris vulpis ), and adult tapeworm ( Taenia pisiformis, Echinococcus multilocularis, E. granulosus, and Dipylidium caninum ) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 520.1447   Milbemycin oxime, lufenuron, and praziquantel tablets.
(a) Specifications. Each tablet contains:
(1) 2.3 milligrams (mg) milbemycin oxime, 46 mg lufenuron, and 22.8 mg praziquantel;
(2) 5.75 mg milbemycin oxime, 115 mg lufenuron, and 57 mg praziquantel;
(3) 11.5 mg milbemycin oxime, 230 mg lufenuron, and 114 mg praziquantel; or
(4) 23 mg milbemycin oxime, 460 mg lufenuron, and 228 mg praziquantel.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use —(1) Dogs —(i) Amount. 0.5 mg milbemycin oxime, 10 mg lufenuron, and 5 mg of praziquantel per kilogram of body weight, once a month.
(ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations ( Ctenocephalides felis ); and for the treatment and control of adult roundworm ( Toxocara canis, Toxascaris leonina ), adult hookworm ( Ancylostoma caninum ), adult whipworm ( Trichuris vulpis ), and adult tapeworm ( Dipylidium caninum, Taenia pisiformis, Echinococcus multilocularis, and E. granulosus ) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 520.1450   Morantel tartrate oral dosage forms.
§ 520.1450a   Morantel tartrate bolus.
(a) Specifications. Each bolus contains 2.2 grams morantel tartrate equivalent to 1.3 grams of morantel base.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.425 of this chapter.
(d) Conditions of use —(1) Amount. One bolus per 500 pounds of body weight (4.4 milligrams per pound of body weight) as a single oral dose. Boluses may be divided in half for more accurate dosing as follows: up to 325 pounds, 1/2 bolus; 326 to 600 pounds, 1 bolus; 601 to 900 pounds, 1 1/2 boluses; and 901 to 1,200 pounds, 2 boluses.
(2) Indications for use. For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms ( Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine ( Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine ( Oesophagostomum radiatum ).
(3) Limitations. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. Do not treat within 14 days of slaughter.
§ 520.1450b   Morantel tartrate cartridge.
(a) Specifications. The drug product consists of a stainless-steel cylinder having both ends closed with polyethylene diffusing discs and containing a morantel tartrate paste. The paste contains 22.7 grams of morantel tartrate equivalent to 13.5 grams of morantel base.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.425 of this chapter.
(d) Conditions of use —(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season.
(2) Indications for use. For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.
(3) Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 106 days of slaughter. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1450c   Morantel tartrate sustained-release trilaminate cylinder/sheet.
(a) Specifications. The drug product consists of a trilaminated, perforated, plastic sheet formed into a cylinder having plastic plugs in its ends. The core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 grams of morantel base.
(b) Sponsor. See 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.425 of this chapter.
(d) Conditions of use —(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season.
(2) Indications for use. For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.
(3) Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 102 days of slaughter. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1451   Moxidectin tablets.
(a) Specifications. Each tablet contains 30, 68, or 136 micrograms of moxidectin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. 3 micrograms per kilogram (1.36 micrograms per pound) of body weight.
(2) Indications for use. To prevent infection by the canine heartworm Dirofilaria immitis and the subsequent development of canine heartworm disease.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1452   Moxidectin gel.
(a) Specifications. Each milliliter of gel contains 20 milligrams (2 percent) moxidectin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Special considerations. See § 500.25 of this chapter.
(d) Conditions of use in horses and ponies —(1) Amount. 0.4 milligram moxidectin per kilogram (2.2 pounds) of body weight.
(2) Indications for use. For the treatment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): Cyathostomum spp., including C. catinatum and C. pateratum ; Cylicocyclus. spp., including C. insigne, C. leptostomum, C. nassatus , and C. radiatus; Cyliocostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus ; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus ; Gyalocephalus capitatus ; and Petrovinema poculatus ; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); and horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars). One dose also suppresses strongyle egg production for 84 days.
(3) Limitations. Do not use in horses intended for human consumption.
§ 520.1453   Moxidectin and praziquantel gel.
(a) Specifications. Each milliliter of gel contains 20 milligrams (mg) (2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Special considerations. See § 500.25 of this chapter.
(d) Conditions of use in horses and ponies —(1) Amount. Administer by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg praziquantel per kilogram (2.2 pounds) body weight.
(2) Indications for use. For the treatment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): ( Cyathostomum spp., including C. catinatum and C. pateratum ; Cylicocyclus spp., including C. insigne, C. leptostomum, C. nassatus , and C. radiatus ; Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus ; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus ; Gyalocephalus capitatus ; and Petrovinema poculatus ; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars); and tapeworms: Anoplocephala perfoliata (adults). One dose also suppresses strongyle egg production for 84 days.
(3) Limitations. Do not use in horses intended for human consumption.
§ 520.1454   Moxidectin solution.
(a) Specifications. Each milliliter (mL) of solution contains 1 milligram (mg) moxidectin.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.426 of this chapter.
(d) Special considerations. See § 500.25 of this chapter.
(e) Conditions of use in sheep —(1) Amount. Administer 1 mL per 11 pounds body weight (1 mL per 5 kilograms) by mouth.
(2) Indications for use. For the treatment and control of the adult and L4 larval stages of Haemonchus contortus , Teladorsagia circumcincta , T. trifurcata , Trichostrongylus axei , T. colubriformis , T. vitrinus , Cooperia curticei , C. oncophora , Oesophagostomum columbianum , O. venulosum , Nematodirus battus , N. filicollis , and N. spathiger.
(3) Limitations. Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption.
§ 520.1468   Naproxen.
(a) Specifications. Each gram of granules contains 500 milligrams (mg) (50 percent) naproxen.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 10 mg per kilogram of body weight twice daily top dressed on feed for up to 14 consecutive days.
(2) Indications for use. For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of 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.
§ 520.1484   Neomycin.
(a) Specifications. (1) Each ounce of powder contains 20.3 grams (g) neomycin sulfate (equivalent to 14.2 g neomycin base).
(2) Each milliliter of solution contains 200 milligrams (mg) neomycin sulfate (equivalent to 140 mg neomycin base).
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section.
(2) Nos. 016592, 054771, 058005, and 061133 for use of product described in paragraph (a)(1) as in paragraphs (e)(1) and (e)(2) of this section.
(3) Nos. 016592, 054771, and 058005 for use of product described in paragraph (a)(2) as in paragraph (e)(1) of this section.
(c) Related tolerances. See § 556.430 of this chapter.
(d) Special labeling considerations. Labeling shall bear the following warning statements: “A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.”
(e) Conditions of use —(1) Cattle, swine, sheep, and goats —(i) Amount. 10 mg per pound (/lb) of body weight per day (22 mg per kilogram (/kg)) in divided doses for a maximum of 14 days.
(ii) Indications for use. For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
(iii) Limitations. Discontinue treatment prior to slaughter as follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Turkeys —(i) Amount. 10 mg/lb of body weight per day (22 mg/kg) for 5 days.
(ii) Indications for use. For the control of mortality associated with E. coli susceptible to neomycin sulfate in growing turkeys.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1510   Nitenpyram.
(a) Specifications. Each tablet contains 11.4 or 57 milligrams (mg) nitenpyram.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter:
(1) No. 021091 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of this section.
(2) No. 000061 for use as in paragraphs (d)(1)(i)(B) and (d)(1)(ii)(B) of this section.
(c) Special considerations. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets as in paragraph (d)(1)(ii)(B) of this section shall be by or on the order of a licensed veterinarian.
(d) Conditions of use —(1) Dogs —(i) Amount. (A) One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as needed, for use as in paragraph (d)(1)(ii)(A) of this section.
(B) One 11.4-mg tablet for dogs weighing less than 25 lb or one 57 mg tablet for dogs weighing more than 25 lbs, once or twice weekly, for use as in paragraph (d)(1)(ii)(B) of this section.
(ii) Indications for use. (A) For the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater.
(B) The concurrent use of nitenpyram tablets as in paragraph (d)(1)(i)(B) of this section with either flavored lufenuron tablets as in § 520.1288(c)(1) of this chapter or flavored milbemycin and lufenuron tablets as in § 520.1443(d)(1) is indicated to kill adult fleas and prevent flea eggs from hatching.
(2) Cats —(i) Amount. (A) One 11.4-mg tablet, as needed, for use as in paragraph (d)(2)(ii)(A) of this section.
(B) One 11.4-mg tablet, once or twice weekly, for use as in paragraph (d)(2)(ii)(B) of this section.
(ii) Indications for use. (A) For the treatment of flea infestations on cats and kittens 4 weeks of age and older and 2 lbs of body weight or greater.
(B) The concurrent use of nitenpyram tablets as in paragraph (d)(2)(i)(B) of this section with flavored lufenuron tablets as in § 520.1288(c)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching.
§ 520.1604   Oclacitinib.
(a) Specifications. Each tablet or chewable tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.
(2) Indications for use. For 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.
§ 520.1615   Omeprazole.
(a) Specifications. Each gram of paste contains 0.37 gram omeprazole.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Special considerations. When labeled for use as in paragraph (d)(2)(i) of this section, product labeling shall bear: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
(d) Conditions of use in horses —(1) Amount. (i) For treatment of gastric ulcers, 1.8 milligrams per pound (mg/lb) of body weight (4 milligrams per kilogram (mg/kg)) once daily for 4 weeks. For prevention of recurrence of gastric ulcers, 0.9 mg/lb of body weight (2 mg/kg) once daily for at least an additional 4 weeks.
(ii) For prevention of gastric ulcers using the premarked syringe, one dose per day for 8 or 28 days. Each dose delivers at least 1 mg/kg of body weight. Horses over 1,200 lb body weight should receive two doses per day.
(2) Indications for use. (i) For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
(ii) For prevention of gastric ulcers in horses.
(3) Limitations. Do not use in horses intended for human consumption.
§ 520.1616   Orbifloxacin tablets.
(a) Specifications. Each tablet contains 5.7, 22.7, or 68 milligrams (mg) orbifloxacin.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. 2.5 to 7.5 mg per kilogram body weight once daily.
(2) Indications for use. For management of diseases associated with bacteria susceptible to orbifloxacin.
(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.
§ 520.1618   Orbifloxacin suspension.
(a) Specifications. Each milliliter of suspension contains 30 milligrams (mg) orbifloxacin.
(b) Sponsor. See No. 000061 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. Federal law prohibits the extralabel use of this drug in food-producing animals.
(d) Conditions of use —(1) Dogs —(i) Amount. 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg) of body weight once daily.
(ii) Indications for use. For the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius , Proteus mirabilis , Escherichia coli, and Enterococcus faecalis and skin and soft tissue infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius , Staphylococcus aureus , coagulase-positive staphylococci, Pasteurella multocida , Proteus mirabilis , Pseudomonas spp., Klebsiella pneumoniae , E. coli , Enterobacter spp., Citrobacter spp., E. faecalis , β-hemolytic streptococci (Group G), and Streptococcus equisimilis.
(2) Cats —(i) Amount. 3.4 mg/lb (7.5 mg/kg) of body weight once daily.
(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of S. aureus , E. coli , and P. multocida.
§ 520.1628   Oxfendazole powder and pellets.
(a) Specifications —(1) Powder for suspension. Each gram of powder contains 7.57 percent oxfendazole.
(2) Pellets. Each gram of pellets contains 6.49 percent oxfendazole.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. 10 milligrams per kilogram of body weight.
(2) Indications for use. The drug is used in horses for removal of the following gastrointestinal worms: Large roundworms ( Parascaris equorum ), mature and immature pinworms ( Oxyuris equi ), large strongyles ( Strongylus edentatus, Strongylus vulgaris, and Strongylus equinus ), and small strongyles.
(3) Limitations —(i) Powder for suspension. For gravity administration via stomach tube or for positive administration via stomach tube and dose syringe. Discard unused portions of suspension after 24 hours. Mix drug according to directions prior to use. Administer drug with caution to sick or debilitated horses. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(ii) Pellets. The drug is given by sprinkling on the grain portion of the ration. Withholding feed or water prior to administration is not necessary. Administer drug with caution to sick or debilitated horses. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1629   Oxfendazole paste.
(a)(1) Specifications. Each gram of paste contains 0.375 gram oxfendazole (37.5 percent).
(2) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(3) Conditions of use —(i) Amount. 10 milligrams per kilogram (2.2 pounds) of body weight.
(ii) Indications for use. The drug is used in horses for removal of the following gastrointestinal worms: Large roundworms ( Parascaris equorum ), mature and 4th stage larvae pinworms ( Oxyuris equi ), large strongyles ( Strongylus edentatus, S. vulgaris, and S. equinus ), and small strongyles.
(iii) Limitations. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks. Withholding feed or water prior to use is unnecessary. Administer drug with caution to sick or debilitated horses. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
(b)(1) Specifications. Each gram of paste contains 185 milligrams of oxfendazole (18.5 percent).
(2) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(3) Related tolerances. See § 556.495 of this chapter.
(4) Conditions of use —(i) Amount. 4.5 milligrams per kilogram of body weight (2.05 milligrams per pound).
(ii) Indications for use. The drug is used in cattle for the removal and control of the following worms: lungworms ( Dictyocaulus viviparus —adult, L4); stomach worms: barberpole worms ( Haemonchus contortus and H. placei —adult), small stomach worms ( Trichostrongylus axei —adult), brown stomach worms ( Ostertagia ostertagi —adult, L4, inhibited L4); intestinal worms; nodular worms ( Oesophagostomum radiatum —adult), hookworms ( Bunostomum phlebotomum —adult), small intestinal worms ( Cooperia punctata, C. oncophora, and C. mcmasteri —adult, L4); and tapeworms ( Moniezia benedeni —adult).
(iii) Limitations. For use in cattle only. Treatment may be repeated in 4 to 6 weeks. Cattle must not be slaughtered until 11 days after treatment. Do not use in female dairy cattle of breeding age. Consult a veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1630   Oxfendazole suspension.
(a) Specifications. Each milliliter of suspension contains:
(1) 90.6 milligrams (mg) oxfendazole (9.06 percent).
(2) 225.0 mg oxfendazole (22.5 percent).
(b) Sponsor. See Nos. 000010 and 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.495 of this chapter.
(d) Special considerations. See § 500.25 of this chapter. If labeled for administration by stomach tube: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use —(1) Horses. Use the product described in paragraph (a)(1) of this section as follows:
(i) Amount. 10 mg per kilogram (/kg) of body weight by stomach tube or dose syringe. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks.
(ii) Indications for use. For removal of large roundworms ( Parascaris equorum ), mature and 4th stage larvae pinworms ( Oxyuris equi ), large strongyles ( Strongylus edentatus, S. vulgaris, and S. equinus ), and small strongyles.
(iii) Limitations. Withholding feed or water prior to use is unnecessary. Administer drug with caution to sick or debilitated horses. Do not use in horses intended for human consumption.
(2) Cattle. Use the products described in paragraphs (a)(1) and (a)(2) of this section as follows:
(i) Amount. 4.5 mg/kg of body weight by dose syringe. Treatment may be repeated in 4 to 6 weeks.
(ii) Indications for use. For the removal and control of: lungworms ( Dictyocaulus viviparus —adult, L4); stomach worms: barberpole worms ( Haemonchus contortus and H. placei —adult), small stomach worms ( Trichostrongylus axei —adult), brown stomach worms ( Ostertagia ostertagi —adult, L4, inhibited L4); intestinal worms; nodular worms ( Oesophagostomum radiatum —adult), hookworms ( Bunostomum phlebotomum —adult), small intestinal worms ( Cooperia punctata, C. oncophora, and C. surnabada —adult, L4), and tapeworms ( Moniezia benedeni —adult).
(iii) Limitations. Cattle must not be slaughtered until 7 days after treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age.
§ 520.1631   Oxfendazole and trichlorfon paste.
(a) Specifications. Each gram of paste contains 28.5 milligrams oxfendazole and 454.5 milligrams trichlorfon.
(b) Sponsor. See 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. 2.5 milligrams of oxfendazole and 40 milligrams of trichlorfon per kilogram of body weight.
(2) Indications for use. The drug is used in horses for removal of bots ( Gasterophilus intestinalis, 2nd and 3rd instars; G. nasalis, 3rd instar) and the following gastrointestinal worms: Large roundworms ( Parascaris equorum ), pinworms ( Oxyuris equi ), adult and 4th stage larvae; large strongyles ( Strongylus edentatus, S. vulgaris, and S. equinus ); and small strongyles.
(3) Limitations. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks. Withholding feed or water before use is unnecessary. Administer with caution to sick or debilitated horses. Not for use in horses intended for food. Do not administer to mares during the last month of pregnancy. Trichlorfon is a cholinesterase inhibitor. Do not use this product in animals simultaneously with, or within a few days before or after treatment with or exposure to, cholinesterase-inhibiting drugs, pesticides, or chemicals. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1638   Oxibendazole.
(a) Specifications. (1) Each gram of paste contains 227 milligrams (mg) (22.7 percent) oxibendazole.
(2) Each milliliter of suspension contains 100 mg (10 percent) oxibendazole.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Special considerations. (1) See § 500.25 of this chapter.
(2) Suspension product described in paragraph (a)(2) of this section shall be labeled: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
(d) Conditions of use in horses —(1) Amount. For uses other than for threadworms ( Strongyloides westeri ), 10 mg oxibendazole per kilogram (/kg) body weight; for threadworms ( Strongyloides westeri ), 15 mg/kg. Horses maintained on premises where reinfection is likely to occur should be re-treated in 6 to 8 weeks. Administer suspension product by stomach tube in 3 to 4 pints of warm water, or by top dressing or mixing into a portion of the normal grain ration.
(2) Indications for use. For removal and control of large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ); small strongyles (genera Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, Cylicodontophorus, and Gyalocephalus ); large roundworms ( Parascaris equorum ); pinworms ( Oxyuris equi ) including various larval stages; and threadworms ( Strongyloides westeri ).
(3) Limitations. Do not use in horses intended for human consumption.
§ 520.1660   Oxytetracycline.
§ 520.1660a   [Reserved]
§ 520.1660b   Oxytetracycline capsules.
(a) Specifications. Each capsule contains 125 or 250 milligrams (mg) oxytetracycline hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer orally 25 to 50 mg per pound of body weight per day in divided doses at 12-hour intervals.
(2) Indications for use. For the treatment of bacterial pneumonia caused by Brucella bronchiseptica, tonsilitis caused by Streptococcus hemolyticus, bacterial enteritis caused by Escherichia coli, urinary tract infections caused by Escherichia coli, and wound infections caused by Staphylococcus aureus.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1660c   Oxytetracycline tablets.
(a) Specifications. Each tablet contains 250 or 500 milligrams (mg) oxytetracycline hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Tolerances. See § 556.500 of this chapter.
(d) Conditions of use in beef and dairy cattle —(1) Amounts. 10 mg per pound of body weight every 12 hours for treatment; 5 mg per pound of body weight every 12 hours for control.
(2) Indications for use. For treatment and control of bacterial enteritis caused by Salmonella typhimurium and Escherichia coli (colibacillosis) and bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida.
(3) Limitations. Discontinue treatment 7 days prior to slaughter. Not for use in lactating dairy cattle. A withdrawal period has not been established for this product 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.
§ 520.1660d   Oxytetracycline powder.
(a) Specifications. The drug is a soluble powder distributed in packets or pails having several concentrations of oxytetracycline hydrochloride (independent of the various net weights) as follows:
(1) Each 18.14 grams of powder contains 1 gram of oxytetracycline hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.).
(2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 and 16 oz.).
(3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs.; and pails: 4.5 lbs.).
(4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb).
(5) Each 4.2 grams of powder contains 1 gram of OTC HCl (packets: 3.8 and 15.2 oz; pails: 4.74 and 23.7 lb).
(6) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 4.78 oz.; pail: 5 lb). Each 2.73 grams of powder contains 1 gram of OTC HCl (packet: 9.87 oz).
(7) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 4.78 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 grams of powder contains 1 gram of OTC HCl (packet: 6.4 oz.; pails: 2 and 5 lb).
(8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC HCl. Each 677.5-gram packet (23.9 ounce) contains 512 grams of OTC HCl.
(9) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 9.87 and, 19.75 oz, and 3.91 lb; pails: 3.09 and 5 lb).
(10) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 9.87 and 19.74 oz; pails: 5 lb).
(b) Sponsor. See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) No. 054771 for use of OTC HCl concentrations in paragraphs (a)(1), (a)(2), and (a)(3) of this section in chickens, turkeys, swine, cattle, sheep, and honey bees.
(2) No. 016592 for use of OTC HCl concentration in paragraph (a)(4) of this section in chickens, turkeys, and swine.
(3) No. 066104 for use of OTC HCl concentration in paragraph (a)(5) of this section in turkeys and chickens.
(4) No. 016592 for use of OTC HCl concentration in paragraph (a)(6) of this section in chickens, turkeys, and swine.
(5) No. 061133 for use of OTC HCl concentration in paragraph (a)(7) of this section in chickens, turkeys, swine, cattle, sheep, and honeybees.
(6) No. 069254 for use of OTC HCl concentrations in paragraph (a)(8) of this section in chickens, turkeys, swine, cattle, sheep, and honey bees.
(7) No. 061133 for use of OTC HCl concentration in paragraph (a)(9) of this section in chickens, turkeys, and swine.
(c) Related tolerances. See § 556.500 of this chapter.
(d) Conditions of use. (1) It is used in drinking water as follows:
(i) Chickens —(A)( 1 ) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.
( 2 ) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline.
( 3 ) Do not use in birds producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B)( 1 ) Amount. Administer 400 to 800 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.
( 2 ) Indications for use. Control of chronic respiratory disease (CRD) and air sac infections caused by Mycoplasma gallisepticum and E. coli susceptible to oxytetracycline; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline.
( 3 ) Do not use in birds producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(ii) Turkeys —(A)( 1 ) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.
( 2 ) Indications for use. Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline.
( 3 ) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B)( 1 ) Amount. Administer 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.
( 2 ) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline.
( 3 ) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(C)( 1 ) Amount. Administer 25 milligrams per pound of body weight daily for 7 to 14 days. Not to be used for more than 14 consecutive days.
( 2 ) Indications for use. Growing turkeys. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline.
( 3 ) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(iii) Swine —(A) Amount. Administer 10 milligrams per pound of body weight daily in drinking water. Administer up to 14 days; do not use for more than 14 consecutive days those products sponsored by Nos. 054771, 061133, and 069254. Administer up to 5 days; do not use for more than 5 consecutive days those products sponsored by Nos. 016592 and 061133.
(B) Indications for use. Control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. For breeding swine: Control and treatment of leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona susceptible to oxytetracycline.
(C) Limitations. Withdraw zero days prior to 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. Administer 10 milligrams per pound of body weight daily for up to 14 days. Do not use for more than 14 consecutive days.
(B) Indications for use. Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline.
(C) Withdraw 5 days prior to slaughter. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(v) Sheep —(A) Amount. Administer 10 milligrams per pound of body weight daily for up to 14 days. Not to be used for more than 14 consecutive days.
(B) Indications for use. Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline.
(C) Withdraw 5 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) It is used in the food of honey bees as follows:
(i) Amount. 200 milligrams per colony, administered via either a 1:1 sugar syrup (equal parts of sugar and water weight to weight) or dusting with a powdered sugar mixture. The drug is administered in 3 applications of sugar syrup or 3 dustings at 4- to 5-day intervals.
(ii) Indications for use. For control of American foulbrood caused by Paenibacillus larvae .
(iii) The drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1664   Oxytetracycline and carbomycin.
(a) Specifications. (1) Oxytetracycline: The antibiotic substance produced by growth of Streptomyces rimosus or the same antibiotic substance produced by any other means.
(2) Carbomycin: The antibiotic substance produced by growth of Streptomyces halstedii or the same antibiotic substance produced by any other means.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Special considerations. The quantities of oxytetracycline in paragraph (e) of this section refer to the activity of oxytetracycline hydrochloride and the quantities of carbomycin listed refer to the activity of an appropriate standard.
(d) Related tolerances. See §§ 556.110 and 556.500 of this chapter.
(e) Conditions of use. It is used as oxytetracycline hydrochloride plus carbomycin base in drinking water of chickens as follows:
(1) Amount. Administer 1.0 gram of oxytetracycline and 1.0 gram carbomycin per gallon for not more than 5 days.
(2) Indications for use. As an aid in the prevention and treatment of complicated chronic respiratory disease (air-sac infection) caused by Mycoplasma gallisepticum and secondary bacterial organisms associated with chronic respiratory disease such as E. coli.
(3) Limitations. Not for use in chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1696   Penicillin.
§ 520.1696a   Penicillin G powder.
(a) Specifications. Each gram of powder contains penicillin G potassium equivalent to 1.54 million units of penicillin G.
(b) Sponsors. See Nos. 016592, 042791, 054771, 061133, and 076475 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.510 of this chapter.
(d) Conditions of use in turkeys —(1) Amount. 1,500,000 units per gallon drinking water for 5 days.
(2) Indications for use. Treatment of erysipelas caused by Erysipelothrix rhusiopathiae.
(3) Limitations. Discontinue treatment at least 1 day prior to slaughter. Not for use in turkeys producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1696c   Penicillin V tablets.
(a) Specifications. Each tablet contains penicillin V potassium equivalent to 125 milligrams (200,000 units) or 250 milligrams (400,000 units) of penicillin V.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. 10 to 15 milligrams per pound of body weight every 6 to 8 hours.
(2) Indications for use. Treatment of respiratory, urogenital, skin and soft tissue infections and septicemia caused by pathogens susceptible to penicillin V potassium.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1705   Pergolide.
(a) Specifications. Each tablet contains 1 milligram (mg) peroglide (as pergolide mesylate).
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer orally at a starting dose of 2 micrograms/kilograms (µ/kg) once daily. Dosage may be adjusted to effect, not to exceed 4 µg/kg daily.
(2) Indications for use. For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing's Disease).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1720   Phenylbutazone oral dosage forms.
§ 520.1720a   Phenylbutazone tablets and boluses.
(a) Specifications. Each tablet contains 100, 200, or 400 milligrams (mg), or 1 gram (g) phenylbutazone. Each bolus contains 1, 2, or 4 g phenylbutazone.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter, as follows:
(1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-g boluses, in dogs and horses.
(2) No. 069043 for use of 100- or 200-mg or 1-g tablets in dogs and horses.
(3) Nos. 054771 and 061133 for use of 100-mg or 1-g tablets in dogs and horses.
(4) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.
(5) No. 058198 for use of 1-g tablets in horses.
(c) Conditions of use —(1) Dogs —(i) Amount. 20 mg per pound of body weight daily.
(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount. 1 to 2 g per 500 pounds of body weight daily.
(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1720b   Phenylbutazone granules.
(a) Specifications. Each package of granules contains 1 or 8 grams of phenylbutazone.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter.
(1) No. 000061 for 8-gram package.
(2) No. 059320 for 1-gram package.
(c) Conditions of use in horses —(1) Amount. Administer 1 to 2 grams per 500 pounds of body weight, not to exceed 4 grams, daily as required. by adding to a portion of the usual grain ration.
(2) Indications for use. For the treatment of inflammatory conditions associated with the musculoskeletal system.
(3) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1720c   Phenylbutazone paste.
(a) Specifications. (1) Each gram of paste contains 0.2 grams phenylbutazone.
(2) Each gram of paste contains 0.35 grams phenylbutazone.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 000061 for use of product described in paragraph (a)(1) of this section.
(2) No. 017030 for use of product described in paragraph (a)(2) of this section.
(c) Conditions of use in horses —(1) Amount. 1 to 2 grams of phenylbutazone per 500 pounds of body weight, not to exceed 4 grams daily.
(2) Indications for use. For relief of inflammatory conditions associated with the musculoskeletal system.
(3) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1720d   Phenylbutazone gel.
(a) Specifications. Each 30 grams of gel contains 4 grams of phenylbutazone.
(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter. require bioequivalency and safety information.
(c) Conditions of use in horses —(1) Amount. 1 to 2 grams of phenylbutazone per 500 pounds of body weight, not to exceed 4 grams daily.
(2) Indications for use. For relief of inflammatory conditions associated with the musculoskeletal system of horses.
(3) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1720e   Phenylbutazone powder.
(a) Specifications. (1) Each 1.15 grams (g) of powder contains 1 g phenylbutazone.
(2) Each 10 g of powder contains 1 g phenylbutazone.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 086119 for use of product described in paragraph (a)(1) of this section.
(2) No. 057699 for use of product described in paragraph (a)(2) of this section.
(c) Conditions of use in horses —(1) Amount. Administer 1 to 2 g (1 to 2 level scoops, using the scoop provided) per 500 pounds of body weight on a small amount of palatable feed, not exceed 4 g per animal daily.
(2) Indications for use. For the relief of inflammatory conditions associated with the musculosketetal system.
(3) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the extralabel use of this product in female cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1760   Phenylpropanolamine.
(a) Specifications. (1) Each chewable tablet contains 25, 50, or 75 milligram (mg) phenylpropanolamine hydrochloride.
(2) Each extended-release tablet contains 18, 38, 74, or 145 mg phenylpropanolamine hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) Nos. 055246 and 086117 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) and (3) of this section.
(2) No. 055246 for use of product described in paragraph (a)(2) of this section as in paragraph (c)(1)(ii) and (c)(2) and)(3) of this section.
(c) Conditions of use in dogs —(1) Amount. Administer orally as follows:
(i) Chewable tablet: 2 mg/kg of body weight twice daily.
(ii) Extended-release tablet: 2 to 4 mg/kg of body weight once daily with food.
(2) Indications for use. For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1780   Pimobendan tablets.
(a) Specifications. Each chewable tablet contains 1.25, 2.5, 5, or 10 milligrams (mg) pimobendan.
(b) Sponsors. See Nos. 000010 and 069043 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally at a total daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into two portions administered approximately 12 hours apart.
(2) Indications for use. For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure ( e.g., furosemide, etc.) as appropriate on a case-by-case basis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1782   Pimobendan solution.
(a) Specifications. Each milliliter of solution contains 1.5 milligrams (mg) pimobendan.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight. The total daily dose should be divided into two equal portions administered approximately 12 hours apart ( i.e., morning and evening).
(2) Indications for use. For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure ( e.g., furosemide, etc.) as appropriate on a case-by-case basis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1802   Piperazine-carbon disulfide complex oral dosage forms.
§ 520.1802a   Piperazine-carbon disulfide complex suspension.
(a) Specifications. Each fluid ounce of suspension contains 7.5 grams of piperazine-carbon disulfide complex. The piperazine-carbon disulfide complex contains equimolar parts of piperazine and carbon disulfide (1 gram contains 530 mgs of piperazine and 470 mgs of carbon disulfide).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses and ponies —(1) Amount. Administer 1 fluid ounce per 100 pounds of body weight by stomach tube or dose syringe after withholding feed overnight or for 8 to 10 hours.
(2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum), bots ( Gastrophilus spp.), small strongyles, large strongyles ( Strongyles spp.), 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.
§ 520.1802b   Piperazine-carbon disulfide complex boluses.
(a) Specifications. Each bolus contains 20 grams of piperazine-carbon disulfide complex.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses and ponies —(1) Amount. For removal of ascarids and small strongyles, 1 bolus (20 grams) per 500 pounds body weight; removal of large strongyles, pinworms, and bots, 1 bolus per 250 pounds body weight.
(2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum ), large strongyles ( Strongylus spp.) bots ( Gastrophilus spp.), small strongyles, and pinworms ( Oxyuris equi ).
(3) Limitations. Withhold feed overnight or for 8 to 10 hours. Give water just before and/or after treatment. Resume regular feeding 4 to 6 hours after treatment. Treatment of debilitated or anemic animals is contraindicated. Do not administer to animals that are or were recently affected with colic, diarrhea, or infected with a serious infectious disease. As with most anthelmintics, drastic cathartics or other gastrointestinal irritants should not be administered in conjunction with this drug. Animals in poor condition or heavily parasitized should be given one half the recommended dose and treated again in 2 or 3 weeks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1802c   Piperazine-carbon disulfide complex with phenothiazine suspension.
(a) Specifications. Each fluid ounce contains 5 grams of piperazine-carbon disulfide complex and 0.83 gram of phenothiazine.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses and ponies —(1) Amount. Administer 1 fluid ounce per 100 pounds of body weight by stomach tube or dose syringe after withholding feed overnight or for 8 to 10 hours.
(2) Indications for use. For removing ascarids (large roundworms, Parascaris equorum ), bots ( Gastrophilus spp.), small strongyles, and large strongyles ( Strongylus spp.).
(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.
§ 520.1803   Piperazine citrate capsules.
(a) Specifications. Each capsule contains piperazine citrate equivalent to 140 milligrams of piperazine base.
(b) Sponsor. See No. 021091 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. The contents of 1 capsule should be mixed with the food of the animal for each 5 pounds, or fraction thereof of body weight, except dogs weighing over 25 pounds should be given the contents of 6 capsules. The drug should be mixed in 1/2 of the regular feeding and when the animal has finished eating the dosed food, the remainder of the food may be given. Dogs and cats may be wormed at 6 to 8 weeks of age. The first treatment should be repeated 10 days later. Reinfection may occur. Repeat treatment if indicated.
(2) Indications for use. For the removal of large roundworms ( Toxocara canis and Toxascaris leonina ).
(3) Limitations. Severely debilitated animals should not be treated except on the advice of a veterinarian.
§ 520.1805   Piperazine phosphate with thenium closylate tablets.
(a) Specifications. Each scored tablet contains the equivalent of 250 milligrams piperazine hexahydrate (as piperazine phosphate) and 125 milligrams thenium (as thenium closylate) or 500 milligrams piperazine hexahydrate (as piperazine phosphate) and 250 milligrams thenium (as thenium closylate).
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer orally to dogs as follows:
Number of Tablets at Each of the Two Doses
(2) Indications for use. For removal of immature (fourth stage larvae) and adult hookworms ( Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala ) and ascarids ( Toxocara canis ) from weaned pups and adult dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1806   Piperazine suspension.
(a) Specifications. Each milliliter of suspension contains piperazine monohydrochloride equivalent to 33.5 milligrams (mg) piperazine base.
(b) Sponsor. See No. 017135 in § 510.600(c) of this chapter.
(c) Special considerations. See § 500.25(c) of this chapter.
(d) Conditions of use in dogs —(1) Indications for use. For the removal of roundworms ( Toxocara canis and Toxascaris leonina ).
(2) Dosage. Administer 20 to 30 mg piperazine base per pound body weight as a single dose.
(3) Limitations. Administer by mixing into the animal's ration to be consumed at one feeding. For animals in heavily contaminated areas, reworm at monthly intervals. Not for use in unweaned pups or animals less than 3 weeks of age.
§ 520.1840   Poloxalene.
(a) Specifications. Polyoxypropylene-polyoxyethylene glycol nonionic block polymer.
(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 as in paragraphs (d)(1) and (d)(3) of this section.
(2) No. 067949 for use as in paragraph (d)(2) of this section.
(3) No. 066104 for use as in paragraph (d)(3) of this section.
(c) Related tolerances. See § 556.517 of this chapter.
(d) Conditions of use. (1) For treatment of legume (alfalfa, clover) bloat in cattle. Administer as a drench at the rate of 25 grams for animals up to 500 pounds and 50 grams for animals over 500 pounds of body weight.
(2) For control of legume (alfalfa, clover) bloat in cattle. Administer, in molasses block containing 6.6 percent poloxalene, at the rate of 0.8 oz. of block (1.5 grams poloxalene) per 100 lbs. of body weight per day.
(3) For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle. A 53-percent poloxalene top dressing on individual rations of ground feed. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily. If bloating conditions are severe, the dose is doubled. Treatment should be started 2 to 3 days before exposure to bloat-producing conditions. Repeat use of the drug if animals are exposed to bloat-producing conditions for more than 12 hours after the last treatment. Do not exceed the double dose in any 24-hour period.
§ 520.1855   Ponazuril.
(a) Specifications. Each gram of paste contains 150 milligrams (mg) ponazuril.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer orally 15 mg per kilogram (kg) (6.81 mg per pound (lb)) body weight as the first dose, followed by 5 mg/kg (2.27 mg/lb) body weight once daily for a period of 27 additional days.
(2) Indications for use. For the treatment of equine protozoal myeloencephalitis 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.
§ 520.1860   Pradofloxacin.
(a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) pradofloxacin.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in cats —(1) Amount. Administer 3.4 mg/lb (7.5 mg/kg) body weight once daily for 7 consecutive days.
(2) Indications for use. For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius.
(3) Limitations. Federal law prohibits the extralabel use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1870   Praziquantel tablets.
(a) Specifications. Each tablet contains:
(1) 34 milligrams (mg) praziquantel.
(2) 11.5 or 23 mg praziquantel.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter.
(1) No. 058198 for use of product described in paragraph (a)(1) of this section as in paragraph (c)(1) of this section and for use of product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section.
(2) Nos. 069043 and 086101 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1) of this section.
(c) Conditions of use —(1) Dogs —(i) Amount. 5 pounds (lb) and under, 1/2 tablet (17 mg); 6 to 10 lb, 1 tablet (34 mg); 11 to 15 lb, 1 1/2 tablets (51 mg); 16 to 30 lb, 2 tablets (68 mg); 31 to 45 lb, 3 tablets (102 mg); 46 to 60 lb, 4 tablets (136 mg); over 60 lb, 5 tablets maximum (170 mg). Administer directly by mouth or crumbled and in feed.
(ii) Indications for use —(A) For removal of canine cestodes Dipylidium caninum and Taenia pisiformis.
(B) For removal of the canine cestode Echinococcus granulosus, and for removal and control of the canine cestode Echinococcus multilocularis.
(iii) Limitations —(A) If labeled only for use as in paragraph (c)(1)(ii)(A) of this section: Not intended for use in puppies less than 4 weeks of age. Consult your veterinarian before administering tablets to weak or debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.
(B) If labeled for use as in paragraph (c)(1)(ii)(B) of this section: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Indications for use. For removal of feline cestodes Dipylidium caninum and Taenia taeniaeformis.
(ii) Dosage. Cats 4 pounds and under, 11.5 mg; 5 to 11 pounds, 23 mg; over 11 pounds, 34.5 mg.
(iii) Limitations. Administer directly by mouth or crumbled and in feed. Not intended for use in kittens less than 6 weeks of age. For over the counter use: Consult your veterinarian before administering tablets to weak or debilitated animals, and for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.1871   Praziquantel and pyrantel.
(a) Specifications. (1) Each tablet contains 13.6 milligrams (mg) praziquantel and 54.3 mg pyrantel base (as pyrantel pamoate), 18.2 mg praziquantel and 72.6 mg pyrantel base (as pyrantel pamoate), or 27.2 mg praziquantel and 108.6 mg pyrantel base (as pyrantel pamoate).
(2) Each chewable tablet contains 30 mg praziquantel and 30 mg pyrantel pamoate or 114 mg praziquantel and 114 mg pyrantel pamoate.
(b) Sponsors. See sponsors in § 510.600(c) for use as in paragraph (d) of this chapter.
(1) See No. 058198 for use of tablets described in paragraph (a)(1) of this section for use as in paragraph (d)(1) of this section.
(2) See No. 051311 for use of tablets described in paragraph (a)(2) of this section for use as in paragraph (d)(2) of this section.
(c) Special considerations. See § 500.25 of this chapter.
(d) Conditions of use —(1) Cats —(i) Dosage. Administer a minimum dose of 2.27 mg praziquantel and 9.2 mg pyrantel pamoate per pound of body weight according to the dosing tables on labeling. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated.
(ii) Indications for use. For removal of tapeworms ( Dipylidium caninum and Taenia taeniaeformis ), hookworms ( Ancylostoma tubaeforme ), and large roundworms ( Toxocara cati ) in cats and kittens.
(iii) Limitations. Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds. Consult your veterinarian before giving to sick or pregnant animals.
(2) Dogs —(i) Amount. Administer a minimum dose of 5 mg praziquantel and 5 mg pyrantel pamoate per kilogram body weight (2.27 mg praziquantel and 2.27 mg pyrantel pamoate per pound body weight) according to the dosing tables on labeling.
(ii) Indications for use. For the treatment and control of roundworms ( Toxocara canis and Toxascaris leonina ), hookworms ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ), and tapeworms ( Dipylidium caninum and Taenia pisiformis ) in dogs and puppies.
§ 520.1872   Praziquantel, pyrantel pamoate, and febantel tablets.
(a) Specifications. Each tablet or chewable tablet contains either:
(1) Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams pyrantel base, and 113.4 milligrams febantel; or
(2) Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel base, and 340.2 milligrams febantel.
(3) Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel base, and 680.4 mg febantel.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer as a single dose directly by mouth or in a small amount of food as follows:
(ii) Indications for use. For the removal of tapeworms ( Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus ); hookworms ( Ancylostoma caninum, Uncinaria stenocephala ); ascarids ( Toxocara canis, Toxascaris leonina ); and whipworms ( Trichuris vulpis ) and for the removal and control of tapeworm Echinococcus multilocularis in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 520.1880   Prednisolone.
(a) Specifications. Each tablet contains 5 or 20 milligrams prednisolone.
(b) Sponsor. See No. 061690 in § 510.600(c)(2) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 2.5 milligrams per 4.5 kilograms (10 pounds) body weight per day. Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced until maintenance level is achieved.
(2) Indications for use. For use as an anti-inflammatory agent.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1892   Pregabalin.
(a) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) pregabalin.
(b) Sponsor. See No. 052483 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer orally as a single dose of 5 mg/kg (0.1 mL/kg) approximately 1.5 hours before the start of the transportation or veterinary visit.
(2) Indications for use. For alleviation of acute anxiety and fear associated with transportation and veterinary visits.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1900   Primidone.
(a) Specifications. Each tablet contains 50 or 250 milligrams of primidone.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 069043 for use of 250 milligram tablets.
(2) No. 054771 for use of 50 and 250 milligram tablets.
(c) Conditions of use in dogs —(1) Amount. Twenty-five milligrams of primidone per pound of body weight (55 milligrams per kilogram of body weight) daily.
(2) Indications for use. For the control of convulsions associated with idiopathic epilepsy, epileptiform convulsions, viral encephalitis, distemper, and hardpad disease that occurs as a clinically recognizable lesion in certain entities in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1920   Prochlorperazine and isopropamide.
(a) Specifications. Each capsules contains either:
(1) 3.33 milligrams of prochlorperazine (as the dimaleate) and 1.67 milligrams of isopropamide (as the iodide); or
(2) 10 milligrams of prochlorperazine (as the dimaleate) and 5 milligrams of isopropamide (as the iodide).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. (i) Capsules described in paragraph (a)(1) of this section are administered orally to dogs weighing from 4 to 15 pounds at the rate of 1 capsule twice daily. These capsules are administered orally to dogs weighing from 16 to 30 pounds at the rate of 1 or 2 capsules twice daily. For dogs weighing less than 4 pounds, administer orally an appropriate fraction of the contents of one of these capsules.
(ii) Capsules described in paragraph (a)(2) of this section are given to dogs weighing 30 pounds and over at the rate of 1 capsule twice daily.
(2) Indications for use. For the treatment of gastrointestinal disturbances associated with emotional stress.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1921   Prochlorperazine, isopropamide, and neomycin.
(a) Specifications. Each capsule contains either:
(1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 milligrams of neomycin base (as the sulfate); or
(2) Capsule No. 3: 10 milligrams of prochlorperazine (as the dimaleate), 5 milligrams of isopropamide (as the iodide), and 75 milligrams of neomycin base (as the sulfate).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer capsules orally twice daily to dogs as follows:
(2) Indications for use. For the treatment infectious bacterial gastroenteritis associated with emotional stress.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.1962   Promazine.
(a) Specifications. Conforms to N.F. XII for promazine hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 0.45 to 0.9 milligrams per pound of body weight mixed with an amount of feed that will be readily consumed.
(2) Indications for use. For quieting excitable, unruly, or intractable horses.
(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.
§ 520.2002   Propiopromazine.
(a) Specifications. Each chewable tablet contains 10 or 20 milligrams of propiopromazine hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer 0.5 to 2.0 milligrams per pound of body weight once or twice daily, depending upon the degree of tranquilization desired.
(2) Indications for use. For oral administration as a tranquilizer. As an aid in handling difficult, excited, and unruly dogs, and in controlling excessive kennel barking, car sickness, and severe dermatitis. It is also indicated for use in minor surgery and prior to routine examinations, laboratory procedures, and diagnostic procedures.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2041   Pyrantel pamoate chewable tablets.
(a) Specifications. Each tablet contains pyrantel pamoate equivalent to 22.7 or 113.5 milligrams pyrantel base.
(b) Sponsor. See Nos. 017135 and 051311 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Provides at least 2.27 milligrams pyrantel base per pound body weight for dogs weighing more than 5 pounds, and at least 4.54 milligrams of pyrantel base per pound body weight for dogs weighing 5 pounds or less.
(2) Indications for use —(i) In dogs and puppies. For removal of ascarids ( Toxocara canis; Toxascaris leonina ) and hookworms ( Ancylostoma caninum; Uncinaria stenocephala ).
(ii) In puppies and adult dogs and in lactating bitches after whelping. To prevent reinfection of Toxocara canis.
(3) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Administer to lactating bitches 2 to 3 weeks after whelping. Retreatment of adult dogs may be necessary at monthly intervals as determined by laboratory fecal examinations. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.2042   Pyrantel pamoate tablets.
(a) Specifications. Each tablet contains pyrantel pamoate equivalent to 22.7, 45.4, or 113.5 milligrams of pyrantel base.
(b) Sponsor. See No. 017135 in § 510.600(c) of this chapter.
(c) Conditions of use. It is used for dogs as follows:
(1) Amount. For dogs weighing over 5 pounds, use at least 2.27 milligrams of pyrantel base per pound of body weight; for dogs weighing 5 pounds or less, use at least 4.54 milligrams of pyrantel base per pound of body weight.
(2) Indications for use. For removal and control of large roundworms (ascarids) ( Toxocara canis and Toxascaris leonina ), and hookworms ( Ancylostoma caninum and Uncinaria stenocephala ).
(3) Limitations. Administer orally directly or in a small amount of food. To prevent reinfection of T. canis in puppies, lactating bitches after whelping, and adult dogs; treat puppies 2, 3, 4, 6, 8, and 10 weeks of age; treat lactating bitches 2 to 3 weeks after whelping; routinely treat adult dogs monthly. Do not withhold food prior to or after treatment. The presence of these parasites should be confirmed by laboratory fecal examination. A followup fecal examination should be conducted 2 to 4 weeks after first treatment regimen to determine the need for re-treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
§ 520.2043   Pyrantel pamoate suspension.
(a) Specifications. (1) Each milliliter (mL) contains pyrantel pamoate equivalent to 50 milligrams (mg) pyrantel base.
(2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg pyrantel base.
(3) Each mL contains pyrantel pamoate equivalent to 4.54 mg pyrantel base.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.
(1) Nos. 054771, 058829, and 069043 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section.
(2) Nos. 054771, 058198, and 058829 for use of the products described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
(3) No. 023851 for use of the product described in paragraph (a)(3) as in paragraph (d)(2) of this section.
(c) Special considerations. See § 500.25 of this chapter.
(d) Conditions of use —(1) Horses and ponies. It is used as follows:
(i) Amount. 3 mg per pound (/lb) body weight as a single dose mixed with the usual grain ration, or by stomach tube or dose syringe.
(ii) Indications for use. For the removal and control of mature infections of large strongyles ( Strongylus vulgaris, S. edentatus, S. equinus ); pinworms ( Oxyuris equi ); large roundworms ( Parascaris equorum ); and small strongyles.
(iii) Limitations. Do not use in horses intended for human consumption. When 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.”
(2) Dogs. It is used as follows:
(i) Dogs and puppies —(A) Amount. 2.27 mg/lb body weight as a single dose in the animal's feed bowl by itself or mixed in a small quantity of food.
(B) Indications for use. For the removal of large roundworms ( Toxocara canis and Toxascaris leonina ) and hookworms ( Ancylostoma caninum and Uncinaria stenocephala ).
(C) Limitations. Additional treatment may be required and should be confirmed by fecal examination within 2 to 4 weeks.
(ii) Dogs, puppies, and lactating bitches after whelping —(A) Amount. 2.27 mg/lb body weight.
(B) Indications for use. To prevent reinfections of T. canis.
(C) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Administer to lactating bitches 2 to 3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals.
§ 520.2044   Pyrantel pamoate paste.
(a) Specifications —(1) Each milliliter (mL) contains 180 milligrams (mg) pyrantel base (as pyrantel pamoate).
(2) Each mL contains 226 mg pyrantel base (as pyrantel pamoate).
(3) Each mL contains 171 mg pyrantel base (as pyrantel pamoate).
(b) Sponsors. See sponsors in § 510.600(c) of this chapter.
(1) No. 054771 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1)(i) and (d)(2) of this section.
(2) No. 017135 for use of product described in paragraph (a)(2) of this section as in paragraph (d) of this section.
(3) No. 061133 for use of product described in paragraph (a)(3) of this section as in paragraph (d)(1)(i) and (d)(2) of this section.
(c) Special considerations. See § 500.25 of this chapter.
(d) Conditions of use. It is used in horses and ponies as follows:
(1) Amounts and indications for use. (i) 3 mg per pound (/lb) body weight as single oral dose for removal and control of infections from the following mature parasites: large strongyles ( Strongylus vulgaris , S. edentatus , S. equinus ); small strongyles; pinworms ( Oxyuris equi ); and large roundworms ( Parascaris equorum ).
(ii) 6 mg/lb body weight as single oral dose for the removal and control of mature infections of tapeworms ( Anoplocephala perfoliata ).
(2) Limitations. Do not use in horses intended for human consumption.
§ 520.2045   Pyrantel tartrate powder.
(a) Specifications. Each gram of powder contains 106 milligrams (10.6 percent) or 113 milligrams (11.3 percent) pyrantel tartrate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of 11.3 percent powder as in paragraph (d)(1) and 10.6 percent powder as in paragraph (d)(2) and of this section.
(c) Related tolerances. See § 556.560 of this chapter.
(d) Conditions of use —(1) Horses —(i) Amount. Administer as a single dose at 0.57 gram of pyrantel tartrate per 100 pounds of body weight mixed with the usual grain ration. Do not administer by stomach tube or dose syringe.
(ii) Indications for use. For the removal and control of infections from the following mature parasites: Large strongyles ( Strongylus vulgaris, S. edentatus, S. equinus ), small strongyles ( Trichonema spp., Triodontophorus ), pinworms ( Oxyuris ), and large roundworms ( Parascaris ).
(iii) Limitations. Do not treat severely debilitated animals with this drug. Do not use in horses intended for human consumption.
(2) Swine —(i) Amount. Add to feed at 0.4 gram pyrantel tartrate per pound of non-pelleted ration. The ration is administered as a single treatment as the sole ration at the rate of 1 pound per 40 pounds of animal weight for animals up to 200 pounds. Animals 200 pounds and over are administered 5 pounds of ration per animal.
(ii) Indications for use. For the removal and control of large roundworms ( Ascaris suum ) and nodular worm ( Oesophagostomum ) infections.
(iii) Limitations. Consult veterinarian before using in severely debilitated animals. Do not treat within 24 hours of slaughter.
§ 520.2046   Pyrantel tartrate pellets.
(a) Specifications. (1) Each gram of pellets contains 12.5 milligrams (mg) (1.25 percent) pyrantel tartrate; or
(2) Each gram of pellets contains 21.1 mg (2.11 percent) pyrantel tartrate.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter:
(1) No. 054771 for use of products described in paragraph (a) as in paragraph (c) of this section.
(2) No. 061133 for use of product described in paragraph (a)(1) as in paragraph (c) of this section.
(c) Conditions of use in horses —(1) Amount. Administer as a single dose at 12.5 mg per 2.2 pounds of body weight mixed with the usual grain ration.
(2) Indications for use. For the removal and control of infections from the following mature parasites: Large strongyles ( Strongylus vulgaris, S. edentatus, S. equinus ), small strongyles ( Trichonema spp., Triodontophorus ), pinworms ( Oxyuris ), and large roundworms ( Parascaris ).
(3) Limitations. Do not treat severely debilitated animals with this drug. Do not use in horses intended for human consumption.
§ 520.2075   Robenacoxib.
(a) Specifications. Each tablet contains 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats.
(b) Sponsors. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer 0.91 mg/lb (2 mg/kg) orally, once daily, for a maximum of 3 days.
(ii) Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats —(i) Amount. Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days.
(ii) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2086   Sarolaner.
(a) Specifications. Each chewable tablet contains 5, 10, 20, 40, 80, or 120 milligrams (mg) sarolaner.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally once a month at the recommended minimum dosage of 0.91 mg/lb (2 mg/kg).
(2) Indications for use. 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), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 1 month in dogs 6 months of age or older and weighing 2.8 pounds or greater. 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.
§ 520.2090   Sarolaner, moxidectin, and pyrantel.
(a) Specifications. Each chewable tablet contains:
(1) 3.0 milligrams (mg) sarolaner, 0.06 mg moxidectin, and 12.5 mg pyrantel (as pamoate salt);
(2) 6.0 mg sarolaner, 0.12 mg moxidectin, and 25.0 mg pyrantel (as pamoate salt);
(3) 12.0 mg sarolaner, 0.24 mg moxidectin, and 50.0 mg pyrantel (as pamoate salt);
(4) 24.0 mg sarolaner, 0.48 mg moxidectin, and 100 mg pyrantel (as pamoate salt);
(5) 48.0 mg sarolaner, 0.96 mg moxidectin, and 200 mg pyrantel (as pamoate salt); or
(6) 72.0 mg sarolaner, 1.44 mg moxidectin, and 300 mg pyrantel (as pamoate salt).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally, once a month, at the recommended minimum dose of 0.54 mg/lb (1.2 mg/kg) sarolaner, 0.011 mg/lb (24 µg/kg) moxidectin, and 2.27 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 ) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala ) infections. Kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment and prevention of flea infestations, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. 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.
§ 520.2098   Selegiline.
(a) Specifications. Each tablet contains 2, 5, 10, 15, or 30 milligrams (mg) selegiline hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amounts and indications for use. (i) Administer 1 mg per kilogram (0.45 mg per pound) of body weight once daily for control of clinical signs associated with uncomplicated pituitary-dependent hyperadrenocorticism in dogs.
(ii) Administer 0.5 to 1.0 mg per kilogram of body weight once daily for the control of clinical signs associated with canine cognitive dysfunction syndrome.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2100   Selenium and vitamin E.
(a) Specifications. Each capsule contains:
(1) 2.19 milligrams (mg) sodium selenite (equivalent to 1 mg selenium) and 56.2 mg (68 I.U.) vitamin E as d-alpha tocopheryl acid succinate; or
(2) 0.548 mg sodium selenite (equivalent to 0.25 mg selenium) and 14 mg (17 I.U.) vitamin E as d-alpha tocopheryl acid succinate.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. (i) Dogs over 20 pounds: Administer 1 capsule described in paragraph (a)(1) per 20 pounds of body weight to a maximum of 5 capsules. Repeat at 3 day intervals until a satisfactory therapeutic response is observed. Maintenance dosage is 1 capsule per 40 pounds of body weight every 3 to 7 days, or longer, as required.
(ii) Dogs under 20 pounds: Administer 1 capsule described in paragraph (a)(2) per 5 pounds of body weight with a minimum of 1 capsule. Repeat at 3-day intervals until a satisfactory response is observed. Maintenance dosage is 1 capsule per 10 pounds of body weight every 3 to 7 days, or longer, as required.
(2) Indications for use. As an aid in alleviating and controlling inflammation, pain, and lameness associated with certain arthropathies.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2123   Spectinomycin oral dosage forms.
§ 520.2123a   Spectinomycin tablets.
(a) Specifications. Each tablet contains spectinomycin dihydrochloride equivalent to 100 milligrams (mg) spectinomycin.
(b) Sponsors. See Nos. 054771 and 061133 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally to provide 10 mg per pound (lb) of body weight twice daily. Dosage may be continued for 4 consecutive days.
(2) Indications for use. For the treatment of infectious diarrhea and gastroenteritis caused by organisms susceptible to spectinomycin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2123b   Spectinomycin powder.
(a) Specifications. Each gram (g) of powder contains spectinomycin dihydrochloride pentahydrate equivalent to 0.5 g spectinomycin.
(b) Sponsor. See No. 061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.600 of this chapter.
(d) Conditions of use in chickens. It is administered in the drinking water of growing chickens as follows:
(1) Indications for use and amounts. (i) As an aid in controlling infectious synovitis due to Mycoplasma synoviae in broiler chickens, administer 1 g per gallon of water as the only source of drinking water for the first 3 to 5 days of life.
(ii) As an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (PPLO) in growing chickens, administer 2 g per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination.
(2) Limitations. Do not administer to laying chickens. Do not administer within 5 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2123c   Spectinomycin solution.
(a) Specifications. Each milliliter of solution contains spectinomycin dihydrochloride pentahydrate equivalent to 50 milligrams (mg) spectinomycin.
(b) Sponsors. See Nos. 016592, 054771, and 061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.600 of this chapter.
(d) Conditions of use in swine —(1) Amount. Administer 5 mg per pound (lb) of body weight orally twice daily for 3 to 5 days.
(2) Indications for use. For the treatment and control of porcine enteric colibacillosis (scours) caused by E. coli susceptible to spectinomycin in pigs under 4 weeks of age.
(3) Limitations. Do not administer to pigs over 15 lb body weight or over 4 weeks of age. Do not administer within 21 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2130   Spinosad.
(a) Specifications. Each chewable tablet contains 140, 270, 560, 810, or 1620 milligrams (mg) spinosad.
(b) Sponsor. See No. 058198 in § 510.600 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. Administer tablets once a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per kilogram) of body weight.
(ii) Indications for use. To kill fleas and for the prevention and treatment of flea infestations ( Ctenocephalides felis ) for 1 month on dogs and puppies 14 weeks of age and older and 5.0 pounds of body weight or greater.
(2) Cats —(i) Amount. Administer tablets once a month at a minimum dosage of 22.5 mg per pound (50 mg per kilogram) of body weight.
(ii) Indications for use. To kill fleas and for the prevention and treatment of flea infestations ( C. felis ) for 1 month on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater.
§ 520.2134   Spinosad and milbemycin.
(a) Specifications. Each chewable tablet contains 140 milligrams (mg) spinosad and 2.3 mg milbemycin oxime, 270 mg spinosad and 4.5 mg milbemycin oxime, 560 mg spinosad and 9.3 mg milbemycin oxime, 810 mg spinosad and 13.5 mg milbemycin oxime, or 1,620 mg spinosad and 27 mg milbemycin oxime.
(b) Sponsor. See No. 058198 in § 510.600 of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer once a month at a minimum dosage of 13.5 mg/pound (lb) (30 mg/kilogram (kg)) of body weight spinosad and 0.2 mg/lb (0.5 mg/kg) of body weight milbemycin oxime.
(2) Indications for use. To kill fleas; for the prevention and treatment of flea infestations ( Ctenocephalides felis ); for the prevention of heartworm disease ( Dirofilaria immitis ); and for the treatment and control of adult hookworm ( Ancylostoma caninum ), adult roundworm ( Toxocara canis and Toxascaris leonina ), and adult whipworm ( Trichuris vulpis ) infections in dogs and puppies 8 weeks of age or older and 5 lbs of body weight or greater.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2138   Spironolactone and benazepril.
(a) Specifications. Each chewable tablet contains 20 milligrams (mg) spironolactone and 2.5 mg benazepril hydrochloride, 40 mg spironolactone and 5 mg benazepril hydrochloride, or 80 mg spironolactone and 10 mg benazepril hydrochloride.
(b) Sponsor. See No. 013744 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally once daily, with food, at a dose of 0.9 mg per pound (lb) (2 mg per kilogram (kg)) spironolactone and 0.11 mg/lb (0.25 mg/kg) benazepril hydrochloride, according to dog body weight using a suitable combination of whole and/or half tablets.
(2) Indications for use. With concurrent therapy ( e.g., furosemide, etc.) for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2150   Stanozolol.
(a) Specifications. Each tablet or chewable tablet contains 2 milligrams stanozolol.
(b) Sponsor. No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount —(i) Dogs: Administered orally to small breeds, 1/2 to 1 tablet twice daily for several weeks; to large breeds, 1 to 2 tablets twice daily for several weeks. The tablets may be crushed and administered in feed.
(ii) Cats: Administered orally 1/2 to 1 tablet twice daily for several weeks.
(2) Indications for use. As an anabolic steroid treatment.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2158   Streptomycin.
(a) Specifications. Each milliliter of solution contains 250 milligrams (25 percent) streptomycin sulfate.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.610 of this chapter.
(d) Conditions of use. Use in drinking water as follows:
(1) Calves —(i) Amount. 10 to 15 milligrams per pound (mg/pound) of body weight (1.0 to 1.5 grams per gallon) for up to 5 days.
(ii) Indications for use. For the treatment of bacterial enteritis caused by Escherichia coli and Salmonella spp. susceptible to streptomycin.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine —(i) Amount. 10 to 15 mg/pound of body weight (1.0 to 1.5 grams per gallon) for up to 4 days.
(ii) Indications for use. For the treatment of bacterial enteritis caused by Escherichia coli and Salmonella spp. susceptible to streptomycin.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Chickens —(i) Amount. 10 to 15 mg/pound of body weight (0.6 to 0.9 grams per gallon) for up to 5 days.
(ii) Indications for use. For the treatment of nonspecific infectious enteritis caused by organisms susceptible to streptomycin.
(iii) Limitations. Withdraw 4 days before slaughter. Do not administer to chickens producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2184   Sulfachloropyrazine.
(a) Specifications. Each gram of powder contains 476 milligrams of sodium sulfachloropyrazine monohydrate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerance. See § 556.625 of this chapter.
(d) Conditions of use in chickens. It is used in the drinking water of broilers, breeder flocks, and replacement chickens as follows:
(1) Amount. Administer in drinking water as 0.03 percent solution for 3 days.
(2) Indications for use. For the treatment of coccidiosis.
(3) Limitations. Withdraw 4 days prior to slaughter. Do not use in chickens producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2200   Sulfachlorpyridazine.
(a) Specifications. (1) Sodium sulfachlorpyridazine powder.
(2) Each milliliter (mL) of suspension contains 50 milligrams (mg) of sodium sulfachlorpyridazine.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.630 of this chapter.
(d) Conditions of use. It is used as follows:
(1) Calves —(i) Amount. Administer 30 to 45 mg sulfachlorpyridazine powder per pound (/lb) of body weight per day in milk or milk replacer in divided doses twice daily for 1 to 5 days.
(ii) Indications for use. For the treatment of diarrhea caused or complicated by Escherichia coli (colibacillosis).
(iii) Limitations. Treated ruminating calves must not be slaughtered for food during treatment or for 7 days after the last treatment. A withdrawal period has not been established for this product 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.
(2) Swine —(i) Amount. Administer 20 to 35 mg/lb body weight per day in divided doses twice daily for 1 to 5 days in drinking water or an oral suspension containing 50 mg per mL.
(ii) Indications for use. For the treatment of diarrhea caused or complicated by E. coli (colibacillosis).
(iii) Limitations. Treated swine must not be slaughtered for food during treatment or for 4 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2215   Sulfadiazine/pyrimethamine suspension.
(a) Specifications. Each milliliter (mL) of suspension contains 250 milligrams (mg) sulfadiazine (as the sodium salt) and 12.5 mg pyrimethamine.
(b) Sponsor. See No. 055246 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer orally 20 mg sulfadiazine per kilogram (kg) body weight and 1 mg/kg pyrimethamine daily.
(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.
§ 520.2218   Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder.
(a) Specifications. Each 195-gram (g) packet of powder contains 78 g sulfamerazine, 78 g sulfamethazine, and 39 g sulfaquinoxaline.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.660, 556.670, and 556.685 of this chapter.
(d) Conditions of use —(1) Chickens —(i) Amounts and indications for use. (A) As an aid in the control of coccidiosis caused by Eimeria tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 to 3 days, then plain water for 3 days, then medicated water (0.025 percent solution) for 2 days. If bloody droppings appear, repeat at 0.025 percent level for 2 more days. Do not change litter.
(B) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 to 3 days. If disease recurs, repeat treatment.
(ii) Limitations. Do not treat chickens within 14 days of slaughter for food. Do not medicate chickens producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Turkeys —(i) Amounts and indications for use. (A) As an aid in the control of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.025 percent solution) for 2 days, then plain water for 3 days, then medicated water (0.025 percent solution) for 2 days, then plain water for 3 days, then medicated water (0.025 percent solution) for 2 days. Repeat if necessary. Do not change litter.
(B) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 to 3 days. If disease recurs, repeat treatment.
(ii) Limitations. Do not treat turkeys within 14 days of slaughter for food. Do not medicate turkeys producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2220   Sulfadimethoxine oral dosage forms.
§ 520.2220a   Sulfadimethoxine oral solution and soluble powder.
(a) Specifications. (1) Each ounce of solution contains 3.75 grams (12.5 percent) sulfadimethoxine.
(2) Each 107 grams of powder contains the equivalent of 94.6 grams sulfadimethoxine as sulfadimethoxine sodium.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter:
(1) Nos. 016592, 054771, 054925, and 069043 for use of the product described in paragraph (a)(1) of this section.
(2) Nos. 016592, 054771, 054925, 058829, 061133, and 066104 for use of the product described in paragraph (a)(2) of this section.
(c) Related tolerances. See § 556.640 of this chapter.
(d) Conditions of use —(1) Broiler and replacement chickens —(i) Amount. Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.
(ii) Indications for use. For treatment of outbreaks of coccidiosis, fowl cholera, and infectious coryza.
(iii) Limitations. Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Turkeys —(i) Amount. Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.
(ii) Indications for use. Growing turkeys: For treatment of disease outbreaks of coccidiosis and fowl cholera.
(iii) Limitations. Withdraw 5 days before slaughter. Do not administer to turkeys over 24 weeks (168 days) of age. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Cattle —(i) Amount. 1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.
(ii) Indications for use. Dairy calves, dairy heifers, and beef cattle: For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum ( Sphaerophorus necrophorus ) sensitive to sulfadimethoxine.
(iii) Limitations. Withdraw 7 days 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this product in lactating dairy cattle.
§ 520.2220b   Sulfadimethoxine suspension.
(a) Specifications. Each milliliter of suspension contains 50 milligrams (mg) sulfadimethoxine.
(b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer orally 25 mg per pound of body weight, followed by 12.5 mg per pound of body weight daily until the animal is free of clinical signs for 48 hours.
(2) Indications for use. For the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and cats and enteritis associated with coccidiosis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2220c   Sulfadimethoxine tablet.
(a) Specifications. Each tablet contains 125, 250, or 500 milligrams (mg) sulfadimethoxine.
(b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use in dogs and cats —(1) Amount. Administer orally 25 mg per pound of body weight, followed by 12.5 mg per pound of body weight daily until the animal is free of clinical signs for 48 hours.
(2) Indications for use. For the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and cats and enteritis associated with coccidiosis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2220d   Sulfadimethoxine bolus.
(a) Specifications. Each bolus contains 2.5, 5, or 15 grams sulfadimethoxine.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.640 of this chapter.
(d) Conditions of use in cattle —(1) Amount. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day; treat for 4 to 5 days.
(2) Indications for use. For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.
(3) Limitations. Do not administer within 7 days of slaughter. Milk that has been taken from animals during treatment and 60 hours (five milkings) after the latest treatment must not be used for food. A withdrawal period has not been established for this product 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.
§ 520.2220e   Sulfadimethoxine extended-release bolus.
(a) Specifications. Each extended-release bolus contains 12.5 grams sulfadimethoxine.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.640 of this chapter.
(d) Conditions of use in beef cattle and non-lactating dairy cattle —(1) Amount. Administer one 12.5-gram-sustained-release bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight. Do not repeat treatment for 7 days.
(2) Indications for use. For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.
(3) Limitations. Do not use in female dairy cattle 20 months of age or older. Do not administer within 12 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2220f   Sulfadimethoxine and ormetoprim tablet.
(a) Specifications. Each tablet contains 120 milligrams (mg) (100 mg sulfadimethoxine and 20 mg ormetoprim), 240 mg (200 mg sulfadimethoxine and 40 mg ormetoprim), 600 mg (500 mg sulfadimethoxine and 100 mg ormetoprim), or 1200 mg (1000 mg sulfadimethoxine and 200 mg ormetoprim).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. On the first day of treatment, administer 25 mg per pound (55 mg per kilogram) of body weight. Then follow with a daily dosage of 12.5 mg per pound (27.5 mg per kilogram) of body weight. Do not exceed a total of 21 consecutive days.
(2) Indications of use. Treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli and urinary tract infections caused by E. coli, Staphylococcus spp., and Proteus mirabilus susceptible to ormetoprim-potentiated sulfadimethoxine.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2240   Sulfaethoxypyridazine.
§ 520.2240a   Sulfaethoxypyridazine solution.
(a) Specifications. Each milliliter of solution contains 62.5 milligrams (mg) sodium sulfaethoxypyridazine.
(b) Sponsor. See No. 054771 § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.650 of this chapter.
(d) Conditions of use —(1) Swine —(i) Amount. Administer 3.8 grams per gallon for first day followed by 1.9 grams per gallon for not less than 3 days nor more than 9 days. Use as the sole source of sulfonamide.
(ii) Indications for use. For treatment of bacterial scours pneumonia enteritis, bronchitis, septicemia accompanying Salmonella choleraesuis infection.
(iii) Limitations. Do not treat within 10 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cattle —(i) Amount. For use at 2.5 grams per gallon. Administer at the rate of 1 gallon per 100 pounds of body weight per day for 4 days. Use as the sole source of sulfonamide.
(ii) Indications for use. For treatment of respiratory infections (pneumonia, shipping fever), foot rot, calf scours; and as adjunctive therapy in septicemia accompanying mastitis and metritis.
(iii) Limitations. Do not treat within 16 days of slaughter. Milk that has been taken from animals during treatment and for 72 hours (6 milkings) after latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2240b   Sulfaethoxypyridazine tablets.
(a) Specifications. (1) Each tablet contains 2.5 or 15 grams sulfaethoxypyridazine.
(2) Each extended-release tablet contains 5 grams sulfaethoxypyridazine.
(b) Sponsor. See No. 054771 § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.650 of this chapter.
(d) Conditions of use in cattle —(1) 2.5- or 15-gram tablets —(i) Amount. Administer 25 milligrams per pound of body weight per day for 4 days. Use as the sole source of sulfonamide.
(ii) Indications for use. For treatment of respiratory infections (pneumonia, shipping fever), foot rot, calf scours; as adjunctive therapy in septicemia accompanying mastitis and metritis.
(iii) Limitations. Do not treat within 16 days of slaughter. Milk that has been taken from animals during treatment and for 72 hours (6 milkings) after latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) 15-gram extended-release tablets —(i) Amount. Administer 100 milligrams per pound of body weight. Use as the sole source of sulfonamide.
(ii) Indications for use. For treatment of foot rot and respiratory infections (shipping fever and pneumonia) caused by sulfonamide-susceptible pathogens ( E. coli, Streptococci, Staphylococci, Sphaerophorus necrophorus and Gram-negative rods including Pasteurella ); and for use prophylactically during periods of stress for reducing losses due to sulfonamide sensitive disease conditions.
(iii) Limitations. Do not treat within 16 days of slaughter. Not for use in lactating dairy cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2260   Sulfamethazine oral dosage forms.
§ 520.2260a   Sulfamethazine oblets and boluses.
(a) Specifications. Each oblet or bolus contains:
(1) 2.5, 5, or 15 grams sulfamethazine.
(2) 5 grams sulfamethazine.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use of products described in paragraph (a) of this section.
(1) No. 016592 for use of products described in paragraph (a)(1) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) of this section.
(c) Related tolerances. See § 556.670 of this chapter.
(d) Conditions of use. (1) Oblets and boluses described in paragraph (a)(1) of this section:
(i) Amount. Administer as a single dose 100 milligrams per pound (mg/lb) of body weight the first day and 50 mg/lb of body weight on each following day.
(ii) Indications for use —(A) Beef cattle and nonlactating dairy cattle. For the treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) ( Pasteurella spp.), colibacillosis (bacterial scours) ( Escherichia coli ), necrotic pododermatitis (foot rot) ( Fusobacterium necrophorum ), calf diphtheria ( Fusobacterium necrophorum ), acute mastitis ( Streptococcus spp.), acute metritis ( Streptococcus spp.), and coccidiosis ( Eimeria bovis and E. zurnii ).
(B) Horses. For the treatment of bacterial pneumonia (secondary infections associated with Pasteurella spp.), strangles ( Streptococcus equi), and bacterial enteritis ( Escherichia coli ).
(iii) Limitations. Do not administer for more than 5 consecutive days. Do not treat cattle within 10 days of slaughter. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Boluses described in paragraph (a)(2) of this section:
(i) Amount. Administer 10 grams (2 boluses) of sulfamethazine per 100 pounds of body weight the first day, then 5 grams (1 bolus) of sulfamethazine per 100 pounds of body weight daily for up to 4 additional consecutive days.
(ii) Indications for use —(A) Ruminating beef and dairy calves. For treatment of the following diseases caused by organisms susceptible to sulfamethazine: bacterial scours (colibacillosis) caused by Escherichia coli; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum; bacterial pneumonia associated with Pasteurella spp.; and coccidiosis caused by Eimeria bovis and E. zurnii.
(B) [Reserved]
(iii) Limitations. Do not administer for more than 5 consecutive days. Do not treat calves within 11 days of slaughter. Do not use in calves to be slaughtered under 1 month of age or in calves being fed an all milk diet. Do not use in female dairy cattle 20 months of age or older; such use may cause drug residues in milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2260b   Sulfamethazine sustained-release boluses.
(a) Related tolerances. See § 556.670 of this chapter.
(b) [Reserved]
(c)(1) Sponsor. See No. 054771 in § 510.600(c) of this chapter for use of a 27-gram sulfamethazine sustained-release bolus.
(2) Conditions of use —(i) Amount. 27 grams (1 bolus) for each 150 pounds of body weight as a single dose.
(ii) Indications for use. For nonlactating cattle for the treatment of infections caused by organisms sensitive to sulfamethazine such as hemorrhagic septicemia (shipping fever complex), bacterial pneumonia, foot rot, and calf diphtheria and as an aid in the control of bacterial diseases usually associated with shipping and handling of cattle.
(iii) Limitations. If no response within 2 to 3 days, reevaluate therapy; do not crush tablets; treated animals must not be slaughtered for food within 28 days after the latest treatment; Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)(1) Sponsor. See No. 061133 in § 510.600(c) of this chapter for use of a 32.1-gram sustained-release bolus.
(2) Conditions of use —(i) Amount. 32.1 grams (1 bolus) per 200 pounds of body weight.
(ii) Indications for use. For beef and nonlactating dairy cattle for the treatment of diseases caused by sulfamethazine-sensitive organisms as follows: bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) caused by Pasteurella spp., colibacillosis (bacterial scours) caused by E. coli, necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum, and acute mastitis and acute metritis caused by Streptococcus spp.)
(iii) Limitations. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. Do not treat animals within 12 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) [Reserved]
(f)(1) Sponsor. See No. 061133 in § 510.600(c) of this chapter for use of an 8.02-gram sulfamethazine sustained-release bolus.
(2) Conditions of use —(i) Amount. Administer 2 boluses (8.02 grams per bolus) per 100 pounds of body weight, as a single dose.
(ii) Indications for use. Administer orally to ruminating calves for the prolonged treatment of the following diseases when caused by one or more of the listed pathogenic organisms sensitive to sulfamethazine: bacterial pneumonia ( Pasteurella spp.), colibacillosis (bacterial scours) ( E. coli ), and calf diphtheria ( Fusobacterium necrophorum ).
(iii) Limitations. For use in ruminating replacement calves only. Do not slaughter animals for food for at least 12 days after the last dose. Exceeding two consecutive doses may cause violative tissue residue to remain beyond the withdrawal time. Do not use in calves under 1 month of age or calves being fed an all milk diet. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(g)(1) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use of a 30-gram sulfamethazine sustained-release bolus.
(2) Conditions of use —(i) Amount. Administer at the rate of 1 bolus (30 grams per bolus) per 200 pounds of body weight, as a single dose.
(ii) Indications for use. Administer orally to beef cattle and nonlactating dairy cattle for the treatment of the following diseases when caused by one or more of the listed pathogenic organisms sensitive to sulfamethazine: bovine respiratory disease complex (shipping fever complex) associated with Pasteurella spp.; bacterial pneumonia associated with Pasteurell spp.; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum ; colibacillosis (bacterial scours) caused by Escherichia coli ; coccidiosis caused by Eimeria bovis and E. zurnii ; acute mastitis and metritis caused by Streptococcus spp.
(iii) Limitations. For use in beef cattle and nonlactating dairy cattle only. Do not slaughter animals for food for at least 8 days after the last dose. Do not use in lactating dairy cattle. Do not administer more than two consecutive doses. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2260c   Sulfamethazine sustained-release tablets.
(a) Specifications. Each extended-release tablet contains 8 grams sulfamethazine.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.670 of this chapter.
(d) Conditions of use —(1) Amount. 8 grams (1 tablet) per 45 pounds of body weight as a single dose.
(2) Indications for use. In calves for sustained treatment of pneumonia caused by Pasteurella spp., colibacillosis (bacterial scours) caused by Escherichia coli; and calf diptheria caused by Fusobacterium necrophorum.
(3) Limitations. Treated animals must not be slaughtered for food within 18 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2261   Sulfamethazine sodium oral dosage forms.
§ 520.2261a   Sulfamethazine solution.
(a) Specifications. Each milliliter of solution contains 125 milligrams (12.5 percent) sulfamethazine sodium.
(b) Sponsors. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.670 of this chapter.
(d) Conditions of use —(1) Amount. Administer in drinking water to provide: Cattle and swine 112.5 milligrams of sulfamethazine sodium per pound of body weight per day on the first day and 56.25 milligrams per pound of body weight on subsequent days; Chickens, 61 to 89 milligrams of sulfamethazine sodium per pound of body weight per day, and turkeys 53 to 130 milligrams of sulfamethazine sodium per pound of body weight per day, depending upon the dosage, age, and class of chickens or turkeys, ambient temperature, and other factors.
(2) Indications for use. For treatment and control of diseases caused by organisms sensitive to sulfamethazine.
(i) Beef and nonlactating dairy cattle. Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) ( Pasteurella spp.), colibacillosis (bacterial scours) ( Escherichia coli ), necrotic pododermatitis (foot rot) ( Fusobacterium necrophorum ), calf diphtheria ( Fusobacterium necrophorum ), acute mastitis ( Streptococcus spp.), and acute metritis ( Streptococcus spp.).
(ii) Swine. Treatment of porcine colibacillosis (bacterial scours) ( Escherichia coli ), and bacterial pneumonia ( Pasteurella spp.).
(iii) Chickens and turkeys. In chickens for control of infectious coryza ( Avibacterium paragallinarum ), coccidiosis ( Eimeria tenella, Eimeria necatrix ), acute fowl cholera ( Pasteurella multocida ), and pullorum disease ( Salmonella Pullorum). In turkeys for control of coccidiosis ( Eimeria meleagrimitis, Eimeria adenoeides ). Medicate as follows: Infectious coryza in chickens, medicate for 2 consecutive days; acute fowl cholera and pullorum disease, in chickens, medicate for 6 consecutive days; coccidiosis, in chickens and turkeys, medicate as in paragraph (c) of this section, then reduce amount of medication to one-half for 4 additional days.
(3) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication from cattle, chickens, and turkeys 10 days prior to slaughter for food. Withdraw medication from swine 15 days before slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days in cattle or swine. Medicated cattle, swine, chickens, and turkeys must actually consume enough medicated water which provides the recommended dosages. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. 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.
§ 520.2261b   Sulfamethazine powder.
(a) Specifications. A soluble powder composed of 100 percent sulfamethazine sodium.
(b) Sponsors. See Nos. 016592 and 061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.670 of this chapter.
(d) Conditions of use —(1) Chickens —(i) Amount. Administer in drinking water to provide 58 to 85 milligrams (mg) per pound (/lb) of body weight per day.
(ii) Indications for use. For control of infectious coryza ( Avibacterium paragallinarum ), coccidiosis ( Eimeria tenella, E. necatrix ), acute fowl cholera ( Pasteurella multocida ), and pullorum disease ( Salmonella Pullorum).
(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Do not medicate chickens producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated chickens must actually consume enough medicated water which provides the recommended dosages. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Turkeys —(i) Amount. Administer in drinking water to provide 50 to 124 mg/lb of body weight per day
(ii) Indications for use. For control of coccidiosis ( E. meleagrimitis , E. adenoeides ).
(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Do not medicate turkeys producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated turkeys must actually consume enough medicated water which provides the recommended dosages. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Swine —(i) Amount. Administer in drinking water, or as a drench, to provide 108 mg/lb of body weight on the first day and 54 mg/lb of body weight per day on the second, third, and fourth days of administration.
(ii) Indications for use. For treatment of porcine colibacillosis (bacterial scours) ( E. coli ), and bacterial pneumonia ( Pasteurella spp.).
(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 15 days prior to slaughter for food. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days. Medicated swine must actually consume enough medicated water which provides the recommended dosages. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Cattle —(i) Amount. Administer in drinking water, or as a drench, to provide 108 mg/lb of body weight on the first day and 54 mg/lb of body weight per day on the second, third, and fourth days of administration.
(ii) Indications for use in beef and nonlactating dairy cattle. Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) ( Pasteurella spp.), colibacillosis (bacterial scours) ( E. coli ), necrotic pododermatitis (foot rot) ( Fusobacterium necrophorum ), calf diphtheria ( F. necrophorum ), acute mastitis ( Streptococcus spp.), and acute metritis ( Streptococcus spp.)
(iii) Limitations. Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication 10 days prior to slaughter for food. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days. Medicated cattle must actually consume enough medicated water which provides the recommended dosages. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. Do not use in calves under one (1) month of age or calves being fed an all-milk diet. Use in these classes of calves may cause violative residues to remain beyond the withdrawal time. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2280   Sulfamethizole and methenamine.
(a) Specifications. Each tablet contains 250 milligrams of sulfamethizole and 250 milligrams of methenamine mandelate.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer orally 1 tablet per 20 pounds of body weight 3 times per day until clinical signs are alleviated. To reduce the possibility of relapse, continue therapy for a week to 10 days.
(2) Indications for use. For treatment of urinary tract infections such as cystitis, nephritis, prostatitis, urethritis, and pyelonephritis. As an aid in the management of complications resulting from surgical manipulations of the urinary tract such as removal of calculi from the bladder, in ureterostomies, and in instrumentation of the urethra and bladder.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2325   Sulfaquinoxaline oral dosage forms.
§ 520.2325a   Sulfaquinoxaline powder and solution.
(a) Sponsor. See § 510.600(c) of this chapter for identification of the sponsors.
(1) To No. 016592 for use of a 25-percent sulfaquinoxaline soluble powder and a 20-percent sulfaquinoxaline sodium solution as provided for in paragraph (c) of this section.
(2) To Nos. 016592 and 054771 for use of a 31.92-percent sulfaquinoxaline solution (sodium and potassium salts) as provided for in paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section.
(3) No. 054771 for use of a 28.62-percent sulfaquinoxaline sodium solution as provided in paragraphs (c)(1), (c)(2), and (c)(3) of this section.
(b) Related tolerances. See § 556.685 of this chapter.
(c) Conditions of use. It is used in drinking water as follows:
(1) Chickens. (i) As an aid in the control of outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti.
(ii) Administer at the 0.04 percent level for 2 or 3 days, skip 3 days then administer at the 0.025 percent level for 2 more days. If bloody droppings appear, repeat treatment at the 0.025 percent level for 2 more days. Do not change litter unless absolutely necessary. Do not give flushing mashes.
(2) Turkeys. (i) As an aid in the control of outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides.
(ii) Administer at the 0.025 percent level for 2 days, skip 3 days, give for 2 days, skip 3 days and give for 2 more days. Repeat if necessary. Do not change litter unless absolutely necessary. Do not give flushing mashes.
(3) Chickens and turkeys. (i) As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline.
(ii) Administer at the 0.04 percent level for 2 or 3 days. Move birds to clean ground. If disease recurs, repeat treatment. If cholera has become established as the respiratory or chronic form, use feed medicated with sulfaquinoxaline. Poultry which have survived typhoid outbreaks should not be kept for laying house replacements or breeders unless tests show they are not carriers.
(4) Cattle and calves. (i) For the control and treatment of outbreaks of coccidiosis caused by Eimeria bovis or E. zurnii.
(ii) Administer at the 0.015-percent level for 3 to 5 days in drinking water medicated with sulfaquinoxaline solution.
(iii) In lieu of treatment as provided in paragraph (c)(4)(ii) of this section, administer 1 teaspoon of 25 percent sulfaquinoxaline soluble powder per day for each 125 pounds of body weight for 3 to 5 days in drinking water.
(d) Limitations. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Not for use in lactating dairy cattle. Do not give to chickens, turkeys, or cattle within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2325b   Sulfaquinoxaline drench.
(a) Specifications. A soluble powder containing 25 percent sulfaquinoxaline.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.685 of this chapter.
(d) Conditions of use in cattle —(1) Amount. Administer 1 teaspoon of 25 percent sulfaquinoxaline soluble powder for each 125 pounds of body weight for 3 to 5 days as a drench.
(2) Indications for use. For the control and treatment of outbreaks of coccidiosis in cattle and calves caused by Eimeria bovis or E. zuernii.
(3) Limitations. Not for use in lactating dairy cattle. A withdrawal period has not been established for this product 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.
§ 520.2330   Sulfisoxazole tablets.
(a) Specifications. Each tablet contains 260 milligrams (4 grains) of sulfisoxazole.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer one tablet orally per 4 pounds of body weight.
(2) Indications for use. Use in dogs and cats as an aid in treatment of bacterial pneumonia and bacterial enteritis when caused by organisms sensitive to sulfisoxazole.
(3) Limitations. Repeat dosage at 24-hour intervals until 2 to 3 days after disappearance of clinical symptoms. (Administration of one-half daily dosage at 12-hour intervals or one-third daily dosage at 8-hour intervals will provide a more constant blood level.) Provide adequate supply of drinking water. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2335   Telmisartan.
(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) telmisartan.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer 1.5 mg/kilogram (kg) (0.68 mg/pound (lb)) orally twice daily for 14 days, followed by 2 mg/kg (0.91 mg/lb) orally once daily.
(2) Indications for use. For the control of systemic hypertension in cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2340   Tepoxalin.
(a) Specifications. Each tablet contains 30, 50, 100, or 200 milligrams (mg) tepoxalin.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 10 mg per kilogram (/kg) daily; or 20 mg/kg on the initial day of treatment, followed by 10 mg/kg daily.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2345   Tetracycline.
§ 520.2345a   Tetracycline capsules.
(a) Specifications. Each capsule contains 50, 100, 125, 250, or 500 milligrams (mg) tetracycline hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 25 mg per pound of body weight per day in divided doses every 6 hours.
(2) Indications for use. For treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2345b   Tetracycline tablets.
(a) Specifications. Each tablet contains 100, 250, or 500 milligrams of tetracycline (as the hydrochloride).
(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 per day in divided doses every 6 hours.
(2) Indications for use. Treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.
(3) Limitations. Administer orally; continue treatment until symptoms of the disease have subsided and temperature is normal for 48 hours; not for use in animals raised for food production; Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2345c   Tetracycline boluses.
(a) Specifications. Each bolus contains 500 milligrams of tetracycline (as the hydrochloride).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.720 of this chapter.
(d) Conditions of use. Calves —(1) Amount. 10 milligrams per pound of body weight per day in divided doses.
(i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia caused by Pasteurella spp., Hemophilus spp., and Klebsiella spp.
(ii) Limitations. Administer orally for 3 to 5 days; do not slaughter animals for food within 14 days of treatment; use as sole source of tetracycline.
(2) Amount. 10 milligrams per pound of body weight per day in two divided doses.
(i) Indications for use. Treatment of bacterial pneumonia caused by organisms susceptible to tetracycline, bacterial enteritis caused by E. coli, and salmonella organisms susceptible to tetracycline.
(ii) Limitations. Administer orally for not more than 5 days; do not slaughter animals for food within 12 days of treatment; use as sole source of tetracycline.
§ 520.2345d   Tetracycline powder.
(a) Specifications. Each pound of powder contains 25, 102.4, or 324 grams tetracycline hydrochloride.
(b) Sponsors. See sponsors listed in § 510.600(c) of this chapter for conditions of use as in paragraph (d) of this section:
(1) No. 054771: 25 grams per pound as in paragraphs (d)(3) and (d)(4) of this section.
(2) No. 066104: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.
(3) Nos. 016592 and 054771: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.
(4) Nos. 016592, 054925, 061133, and 076475: 324 grams per pound as in paragraph (d) of this section.
(5) No. 016592: 25 grams per pound as in paragraphs (d)(1) and (d)(2) of this section.
(c) Related tolerances. See § 556.720 of this chapter.
(d) Conditions of use. It is administered in drinking water as follows:
(1) Calves —(i) Amount. 10 milligrams per pound of body weight per day in divided doses.
(ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Haemophilus spp.), and Klebsiella spp., susceptible to tetracycline.
(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 4 days of treatment for No. 066104 and within 5 days of treatment for Nos. 016592, 054771, 054925, 057561, and 061133; prepare a fresh solution daily; use as the sole source of tetracycline. A withdrawal period has not been established for this product 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.
(2) Swine —(i) Amount. 10 milligrams per pound of body weight per day in divided doses.
(ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae (Haemophilus spp.), and Klebsiella spp., susceptible to tetracycline.
(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 7 days of treatment for No. 066104 and within 4 days of treatment for Nos. 016592, 054771, 054925, 057561, and 061133; prepare a fresh solution daily; use as the sole source of tetracycline. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Chickens —(i) Amount. Chronic respiratory disease: 400 to 800 milligrams per gallon. Infectious synovitis: 200 to 400 milligrams per gallon.
(ii) Indications for use. Control of chronic respiratory disease (CRD or air-sac disease) caused by Mycoplasma gallisepticum and E. coli ; control of infectious synovitis caused by M. synoviae susceptible to tetracycline.
(iii) Limitations. Administer for 7 to 14 days; do not slaughter for food within 4 days of treatment; not for use in chickens producing eggs for human consumption; prepare a fresh solution daily; use as the sole source of tetracycline. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Turkeys —(i) Amount. For infectious synovitis: 400 milligrams per gallon. For complicating bacterial organisms associated with bluecomb (transmissible enteritis or coronaviral enteritis): 25 milligrams per pound of body weight per day.
(ii) Indications for use. Control of infectious synovitis caused by M. synoviae ; control of bluecomb complicated by organisms sensitive to tetracycline.
(iii) Limitations. Administer for 7 to 14 days; do not slaughter for food within 4 days of treatment; not for use in turkeys producing eggs for human consumption; prepare a fresh solution daily; use as the sole source of tetracycline. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2345e   Tetracycline solution.
(a) Specifications. Each milliliter contains the equivalent of either 25 or 100 milligrams of tetracycline hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.
(ii) Indications for use. Treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to Escherichia coli and urinary tract infections due to Staphylococcus spp. and E. coli.
(iii) Limitations. Administer orally; continue treatment until symptoms have subsided and the temperature is normal for 48 hours; not for use in animals which are raised for food production; Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs and cats —(i) Amount. 25 milligrams per pound of body weight per day in divided doses every 6 hours.
(ii) Indications for use. Treatment of infections caused by organisms susceptible to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.
(iii) Limitations. Administer orally; continue treatment until the temperature has been normal for 48 hours; not for use in food-producing animals; Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2345f   Tetracycline phosphate complex and sodium novobiocin capsules.
(a) Specifications. Each capsule contains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 milligrams of novobiocin.
(b) Sponsor. No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 10 milligrams of each antibiotic per pound of body weight (1 capsule for each 6 pounds) every 12 hours.
(2) Indications for use. Treatment of acute or chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2345g   Tetracycline hydrochloride and sodium novobiocin tablets.
(a) Specifications. Each tablet contains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 milligrams of novobiocin, or 180 milligrams of tetracycline hydrochloride and 180 milligrams of novobiocin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 10 milligrams of each antibiotic per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds).
(2) Indications for use. Treatment of acute or chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2345h   Tetracycline hydrochloride, sodium novobiocin, and prednisolone tablets.
(a) Specifications. Each tablet contains the equivalent of 60 milligrams of tetracycline hydrochloride, 60 milligrams of novobiocin, and 1.5 milligrams of prednisolone or 180 milligrams of tetracycline hydrochloride, 180 milligrams of novobiocin, and 4.5 milligrams of prednisolone.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. 10 milligrams of each antibiotic and 0.25 milligram of prednisolone per pound of body weight (one single-strength tablet for each 6 pounds or one triple-strength tablet for each 18 pounds) every 12 hours for 48 hours. Treatment is to be continued with novobiocin and tetracycline alone at the same dose schedule for an additional 3 days or longer as needed.
(2) Indications for use. Treatment of acute and chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli, when it is necessary to initially reduce the severity of associated clinical signs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2362   Thenium closylate.
(a) Specifications. Each tablet contains thenium closylate equivalent to 500 milligrams thenium base.
(a) Specifications. Thenium closylate tablets contain thenium closylate equivalent to 500 milligrams thenium as base in each tablet.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Dogs weighing over 10 pounds: Administer 1 tablet as a single dose. Dogs weighing 5 to 10 pounds: Administered one-half tablet twice during a single day. Repeat treatment after 2 or 3 weeks.
(2) Indications for use. For treatment of canine ancylostomiasis by the removal from the intestines of the adult forms of the species Ancylostoma caninum and Uncinaria stenocephala (hookworms).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2382   Thiabendazole and triclorfon.
(a) Specifications. The drug contains 5 grams of thiabendazole with 4.5 grams of trichlorfon, or 20 grams of thiabendazole with 18 grams of trichlorfon.
(b) Sponsor. See No. 017135 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer 2 grams of thiabendazole with 1.8 grams of trichlorfon per 100 pounds of body weight sprinkled on the animals' usual daily ration of feed, or may be mixed in 5 to 10 fluid ounces of water and administered by stomach tube or drench.
(2) Indications for use. For the treatment and control of bots ( Gasterophilus spp.), large strongyles ( Strongylus spp.), small strongyles (genera Cyathostomum, Cylicobrachytus, Craterostomum, Oesophagodontus, Poteriostomum ), pinworms ( Oxyuris spp., Strongyloides spp.), and ascarids ( Parascaris spp.).
(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.
§ 520.2455   Tiamulin.
(a) Specifications. (1) Each gram of soluble powder contains 450 milligrams (mg) tiamulin hydrogen fumarate.
(2) Each milliliter (mL) of solution contains 125 mg (12.5 percent) tiamulin hydrogen fumarate.
(3) Each mL of solution contains 123 mg (12.3 percent) tiamulin hydrogen fumarate.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 058198 for products described in paragraph (a) of this section.
(2) No. 066104 for product described in paragraph (a)(1) of this section.
(3) Nos. 016592, 051072, 051311, and 061133 for product described in paragraph (a)(2) of this section.
(4) No. 054771 for product described in paragraph (a)(3) of this section.
(c) Related tolerances. See § 556.732 of this chapter.
(d) Conditions of use in swine —(1) Amounts and indications for use. Administer in drinking water for 5 consecutive days:
(i) 3.5 mg per (/) lb of body weight daily for treatment of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin.
(ii) 10.5 mg/lb of body weight daily for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin.
(2) Limitations. Use as only source of drinking water. Prepare fresh medicated water daily. Withdraw medication 3 days before slaughter following treatment at 3.5 mg/lb and 7 days before slaughter following treatment at 10.5 mg/lb of body weight. Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramicin) as adverse reactions may occur. The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined.
§ 520.2471   Tilmicosin.
(a) Specifications. Each milliliter of concentrate solution contains 250 milligrams (mg) tilmicosin as tilmicosin phosphate.
(b) Sponsors. See Nos. 016592 and 058198 in § 510.600(c) of this chapter.
(c) Tolerances. See § 556.735 of this chapter.
(d) Conditions of use in swine —(1) Amount. Administer in drinking water at a concentration of 200 mg per liter for 5 consecutive days.
(2) Indications for use. (i) For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
(ii) For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
(3) Limitations. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this product. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2473   Tioxidazole oral dosage forms.
§ 520.2473a   Tioxidazole granules.
(a) Specifications. Each gram of granules contains 200 milligrams of tioxidazole.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Horses —(i) Amount. 5 milligrams per pound of body weight as a single dose.
(ii) Indications for use. Removal of mature large strongyles ( Strongylus edentatus, S. equinus, and S. vulgaris ), mature ascarids ( Parascaris equorum ), mature and immature (4th larval stage) pinworms ( Oxyuris equi ), and mature small strongyles ( Triodontophorus spp.).
(iii) Limitations. For administration with feed: Sprinkle required amount of granules on a small amount of the usual grain ration and mix. Prepare for each horse individually. Withholding of feed or water not necessary. Not for use in horses intended for food. The reproductive safety of tioxidazole in breeding animals has not been determined. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. It is recommended that this drug be administered with caution to sick or debilitated horses.
(2) [Reserved]
§ 520.2473b   Tioxidazole paste.
(a) Specifications. Each plastic syringe contains 6.25 grams of tioxidazole.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Horses —(i) Amount. 5 milligrams of tioxidazole per pound of body weight as a single dose.
(ii) Indications for use. Removal of mature large strongyles ( Strongylus edentatus, S. equinus, and S. vulgaris ), mature ascarids ( Parascaris equorum ), mature and immature (4th larval stage) pinworms ( Oxyuris equi ), and mature small strongyles ( Triodontophorus spp.).
(iii) Limitations. Administer orally by inserting the nozzle of the syringe through the space between front and back teeth and deposit the required dose on the base of the tongue. Before dosing, make sure the horse's mouth contains no feed. Not for use in horses intended for food. The reproductive safety of tioxidazole in breeding animals has not been determined. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. It is recommended that this drug be administered with caution to sick or debilitated horses.
(2) [Reserved]
§ 520.2475   Toceranib.
(a) Specifications. Each tablet contains 10, 15, or 50 milligrams (mg) toceranib as toceranib phosphate.
(b) Sponsor. See No. 054771 in § 510.600 of this chapter.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer an initial dose of 3.25 mg per kilogram (1.48 mg per pound) body weight, orally every other day.
(ii) Indications for use. For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
§ 520.2520   Trichlorfon oral dosage forms.
§ 520.2520a   Trichlorfon and atropine.
(a) Specifications. (1) For trichlorfon: O,O-Dimethyl 2,2,2-trichloro-1-hydroxyethyl phosphonate.
(2) For atropine: Atropine N.F.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in mice —(1) Amount. Administer 1.67 grams of trichlorfon and 7.7 milligrams of atropine per liter continuously for 7 to 14 days as the sole source of drinking water.
(2) Indications for use. For the treatment of Syphacia obvelata (pinworm) in laboratory mice.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2520b   Trichlorfon boluses.
(a) Specifications. Each bolus contains either 7.3, 10.9, 14.6, or 18.2 g of trichlorfon.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 18.2 milligrams per pound of body weight, except for strongyles use 36.4 milligrams per pound of body weight.
(2) Indications for use. For horses for removal of bots ( Gastrophilus nasalis, Gastrophilus intestinalis ), large strongyles ( Strongylus vulgaris ), small strongyles, large roundworms (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.
§ 520.2520c   Trichlorfon granules.
(a) Specifications. Each package contains either 18.2 or 36.4 g of trichlorfon.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 18.2 milligrams per pound of body weight.
(2) Indications for use. For horses for removal of bots ( Gastrophilus nasalis, Gastrophilus intestinalis ), large roundworms (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.
§ 520.2520d   Trichlorfon, phenothiazine, and piperazine.
(a) Specifications. Each 54.10 grams (1.91 ounces) of water dispersible powder contains 9.10 grams of trichlorfon, 6.25 grams of phenothiazine, and the equivalent of 20.0 grams of piperazine base (as piperazine dihydrochloride).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. 18.2 milligrams (mg) of trichlorfon, 12.5 mg of phenothiazine, and 40 mg of piperazine base per pound of body weight.
(2) Indications for use. For removal of bots ( Gastrophilus nasalis, Gastrophilus intestinalis ), large strongyles ( Strongylus vulgaris ), small strongyles, large roundworms (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.
§ 520.2582   Triflupromazine.
(a) Specifications. Each tablet contains 10 or 25 milligrams (mg) triflupromazine hydrochloride.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats —(1) Amount. Administer orally 1 to 2 mg per pound of body weight daily, followed by 1 mg daily.
(2) Indications for use. For relief of anxiety, to help control psychomotor over-activity, and to increase the tolerance of animals to pain and pruritus. For use in various clinical procedures which require the aid of a tranquilizer, antiemetic, or preanesthetic.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2598   Trilostane.
(a) Specifications. Each capsule contains 5, 10, 20, 30, 60, or 120 milligrams (mg) trilostane.
(b) Sponsor. See No. 043264 in § 510.600 of this chapter.
(c) Conditions of use in dogs —(1) Amount. The starting dose is 1.0 to 3.0 milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a day.
(2) Indications for use. For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2604   Trimeprazine and prednisolone tablets.
(a) Specifications. Each tablet contains 5 milligrams (mg) trimeprazine tartrate and 2 mg prednisolone.
(b) Sponsors. See Nos. 054771 and 086117 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally an initial dosage: for dogs weighing up to 10 pounds, 1/2 tablet twice daily; for dogs weighing 11 to 20 pounds, 1 tablet twice daily; for dogs weighing 21 to 40 pounds, 2 tablets twice daily; and for dogs weighing over 40 pounds, 3 tablets twice daily. After 4 days, reduce dosage to one-half the initial dose or to an amount sufficient to maintain remission of symptoms.
(2) Indications for use. For the relief of itching regardless of cause; and for reduction of inflammation commonly associated with most skin disorders of dogs such as eczema, caused by internal disorders, otitis, and dermatitis, allergic, parasitic, pustular, and nonspecific origins. As adjunctive therapy in various cough conditions including treatment of “kennel cough” or tracheobronchitis, bronchitis including allergic bronchitis, infections, and coughs of nonspecific origin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2605   Trimeprazine and prednisolone capsules.
(a) Specifications. Each capsule contains:
(1) 3.75 milligrams (mg) trimeprazine in sustained released form (as trimeprazine tartrate) and 1 mg prednisolone (Capsule No. 1); or
(2) 7.5 mg trimeprazine in sustained release form (as trimeprazine tartrate) and 2 mg prednisolone (Capsule No. 2).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally once daily an initial dosage:
(i) For dogs weighing up to 10 pounds: one Capsule No. 1;
(ii) For dogs weighing 11 to 20 pounds, one Capsule No. 2 or two Capsule No. 1;
(iii) For dogs weighing 21 to 40 pounds, two Capsule No. 2 or four Capsule No. 1; and
(iv) For dogs weighing over 40 pounds, three Capsule No. 2 or six Capsule No. 1. After 4 days, the dosage is reduced to approximately 1/2 the initial dosage or to an amount just sufficient to maintain remission of symptoms.
(2) Indications for use. For the relief of itching regardless of cause; and for reduction of inflammation commonly associated with most skin disorders of dogs such as eczema, caused by internal disorders, otitis, and dermatitis, allergic, parasitic, pustular and nonspecific. As adjunctive therapy in various cough conditions including treatment of “kennel cough” or tracheobronchitis, bronchitis including allergic bronchitis, in tonsillitis, acute upper respiratory infections and coughs of nonspecific origin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2610   Trimethoprim and sulfadiazine tablets.
(a) Specifications. Each tablet contains 30 milligrams (mg) (5 mg trimethoprim and 25 mg sulfadiazine), 120 mg (20 mg trimethoprim and 100 mg sulfadiazine), 480 mg (80 mg trimethoprim and 400 mg sulfadiazine) or 960 mg (160 mg trimethoprim and 800 mg sulfadiazine).
(b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs —(1) Amount. Administer orally at 30 mg per kilogram of body weight (14 milligrams per pound) once daily. Alternatively, especially in severe infections, the initial dose may be followed by one-half the recommended daily dose every 12 hours. Administer for 2 to 3 days after symptoms have subsided. Do not treat for more than 14 consecutive days.
(2) Indications for use. The drug is used in dogs where systemic antibacterial action against sensitive organisms is required, either alone or as an adjunct to surgery or debridement with associated infection. The drug is indicated where control of bacterial infection is required during the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, wound infections, and abscesses.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2611   Trimethoprim and sulfadiazine paste.
(a) Specifications. Each gram (g) of paste contains 67 milligrams (mg) trimethoprim and 333 mg sulfadiazine.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter:
(1) No. 054771 for product administered as in paragraph (c)(1)(i) of this section.
(2) No. 000061 for product administered as in paragraph (c)(1)(ii) of this section.
(c) Conditions of use in horses —(1) Amount. Administer orally as a single daily dose for 5 to 7 days:
(i) 5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight per day.
(ii) 3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfadiazine) per 110 pounds (50 kilograms) of body weight per day.
(2) Indications for use. For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory infections, acute urogenital infections, and wound infections and abscesses.
(3) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2612   Trimethoprim and sulfadiazine suspension.
(a) Specifications. Each milliliter (mL) of suspension contains:
(1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or
(2) 400 mg combined active ingredients (67 mg trimethoprim and 333 mg sulfadiazine).
(b) Sponsors. See sponsor numbers in § 510.600 of this chapter:
(1) No. 000061 for use of product described in paragraph (a)(1) for use as in paragraph (c)(1) of this section.
(2) No. 051072 for use of product described in paragraph (a)(2) for use as in paragraph (c)(2) of this section.
(c) Conditions of use —(1) Dogs —(i) Amount. Administer 1 mL (10 mg trimethoprim and 50 mg sulfadiazine) per 5 pounds (lb) of body weight once daily, or one-half the recommended daily dose every 12 hours, for up to 14 consecutive days.
(ii) Indications for use. The drug is used in dogs where systemic antibacterial action against sensitive organisms is required, either alone or as an adjunct to surgery or debridement with associated infection. The drug is indicated where control of bacterial infection is required during the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, wound infections, and abscesses.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses —(i) Amount. Administer orally at a dosage of 24 mg combined active ingredients per kilogram body weight (10.9 mg/lb) twice daily for 10 days. Administered by volume at 2.7 mL per 45.4 kilograms of body weight (2.7 mL/100 lb).
(ii) Indications for use. For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus.
(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.
§ 520.2613   Trimethoprim and sulfadiazine powder.
(a) Specifications. Each gram of powder contains 67 milligrams (mg) trimethoprim and 333 mg sulfadiazine.
(b) Sponsors. See Nos. 054771 and 059051 in § 510.600(c) of this chapter.
(c) Conditions of use in horses —(1) Amount. Administer orally 3.75 grams of powder per 110 pounds (50 kilograms) of body weight in a small amount of feed, as a single daily dose, for 5 to 7 days.
(2) Indications for use. For control of bacterial infections of horses during treatment of acute strangles, respiratory tract infections, acute urogenital infections, wound infections, and abscesses.
(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.
§ 520.2640   Tylosin.
(a) Specifications. Each container of soluble powder contains tylosin tartrate equivalent to:
(1) 100 grams (g) tylosin base, or
(2) 256 g tylosin base.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section:
(1) Nos. 016592 and 058198 for use of the 100-g container as in paragraph (e) of this section
(2) No. 061133 for use of the 100-or 256-g container as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section.
(3) No. 061133 for use of a 100-g container as in paragraphs (e)(1)(i)(B) and (e)(1)(ii) of this section.
(c) Related tolerances. See § 556.746 of this chapter.
(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use —(1) Chickens —(i) Amounts and indications for use. (A) Administer 2 grams per gallon (528 parts per million (ppm)) for 1 to 5 days as an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum in broiler and replacement chickens. For the control of CRD associated with M. gallisepticum at time of vaccination or other stress in chickens. For the control of CRD associated with Mycoplasma synoviae in broiler chickens. Treated chickens should consume enough medicated drinking water to provide 50 milligrams (mg) tylosin per pound of body weight per day.
(B) Administer 851 to 1,419 mg/gallon (225 to 375 ppm) for 5 days for the control of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens.
(ii) Limitations. Do not use in layers producing eggs for human consumption. Do not administer within 24 hours of slaughter.
(2) Turkeys —(i) Amount. 2 grams per gallon (528 ppm) for 2 to 5 days as the sole source of drinking water. Treated turkeys should consume enough medicated drinking water to provide 60 mg tylosin per pound of body weight per day.
(ii) Indications for use. For the reduction in severity of effects of infectious sinusitis associated with Mycoplasma gallisepticum.
(iii) Limitations. Do not use in layers producing eggs for human consumption. Do not administer within 5 days of slaughter.
(3) Swine —(i) Amount. 250 mg per gallon (66 ppm) as the only source of drinking water for 3 to 10 days, depending on the severity of the condition being treated.
(ii) Indications for use. (A) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate medicated feed; and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate medicated feed.
(B) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae.
(iii) Limitations. Do not administer within 48 hours of slaughter. As indicated in paragraph (d)(3)(ii)(A) of this section, follow with tylosin phosphate medicated feed as in § 558.625(f)(1)(vi)( c ) of this chapter.
(4) Honey bees —(i) Amount. Mix 200 milligrams tylosin in 20 grams confectioners'/powdered sugar. Use immediately. Apply (dust) this mixture 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 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.
§ 520.2645   Tylvalosin.
(a) Specifications. Granules containing 62.5 percent tylvalosin (w/w) as tylvalosin tartrate.
(b) Sponsor. See No. 066916 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.748 of this chapter.
(d) Conditions of use in swine —(1) Amount. Administer 50 parts per million (ppm) tylvalosin continuously in drinking water for 5 consecutive days.
(2) Indications for use. For control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine intended for slaughter and female swine intended for breeding in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups of swine intended for slaughter and female swine intended for breeding in buildings experiencing an outbreak of SRD.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 520.2654   Velagliflozin.
(a) Specifications. Each milliliter of solution contains 15 milligrams (mg) velagliflozin.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Conditions of use —(1) Amount. Administer orally 0.45 mg per pound of body weight (1 mg per kilogram) velagliflozin once daily.
(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.