Food and Drug Regulations — C.01.021
C.01.021 Except as provided in these Regulations, no person shall sell a drug for human use listed in the following table unless both the inner and the outer labels other than the inner label of a single dose container carry a statement of (a) the quantitative content of the drug, (b) the recommended single and daily adult dose designated as such, except for (i) preparations solely for external use, or (ii) preparations solely for children’s use; and (c) adequate directions for use when the drug is recommended for children which shall be either (i) the statement “CHILDREN: As directed by the physician”, or (ii) a suitable reduced maximum single and daily dose which shall not exceed the following: Age in years Proportion of adult dose 10 - 14 one-half 5 - 9 one-fourth 2 - 4 one-sixth under 2 years as directed by physician TABLE Table of Limits of Drug Dosage for Adults Item External Use Internal Use — — Maximum Limit Maximum Dosage Unless otherwise stated, doses are in milligrams Per cent Single Daily Acetaminophen — 650 4.0 g Acetanilide and derivatives (except N-Acetyl-ρ-amino phenol) — 65 195 Acetylsalicylic Acid — 650 4.0 g Aconitine, its preparations and derivatives 0.2 0.1 0.1 Adonis vernalis — 65 195 Amylocaine, its salts and derivatives when sold or recommended for opthalmic use 0.0 0.0 0.0 Amylocaine Hydrochloride, except when sold or recommended for ophthalmic use 1.0 0.0 0.0 Antimony, compounds of — 3.3 13 Atropine, Methylatropine, and their salts 1.0 0.13 0.44 Belladonna and its preparations, on the basis of belladonna alkaloids 0.375 0.13 0.44 Benzene (Benzol) — — — Benzocaine 8.0 195 585 Beta-Naphthol — 195 585 Butacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.0 0.0 0.0 Butacaine Sulphate, except when sold or recommended for opthalmic use 1.0 0.0 0.0 Cadexomer Iodine 0.0 0.0 0.0 Cantharides, cantharidin, and their preparations, on the basis of cantharidin, except blisters 0.03 0.0 0.0 Cantharides, blisters only 0.2 0.0 0.0 Cedar Oil 25.0 0.0 0.0 Chlorbutol (not more often than every 4 hours) — 325 975 Choline Salicylate — 870 5.22 g Cinchocaine Hydrochloride, except suppositories 1.0 0.0 0.0 Cinchocaine Hydrochloride, suppositories only — 11 11 Colchicine and its salts — 0.55 1.65 Colchicum and its preparations, on the basis of colchicine — 0.27 0.81 Croton Oil 10.0 0.0 0.0 Cyproheptadine and its salts — when sold or recommended for the promotion of weight gain — 0.0 0.0 Ephedrine and its salts — 11 32.5 Ephedrine and its salts, sprays 1.0 — — Epinephrine and its salts, sprays 1.0 — — Gelseminine (Gelsemine) and its salts (not to be repeated within 4 hours) — 0.55 1.65 Gelsemium and its preparations, on the basis of the crude drug — 16.2 48.6 Hydrocyanic (Prussic) Acid as 2 per cent solution — 0.062 ml 0.31 ml Hydroquinone 2.0 — — Hyoscine (Scopolamine) and its salts 0.5 0.325 0.975 Hyoscine aminoxide hydrobromide 0.5 0.325 0.975 Hyoscyamine and its salts — 0.325 0.975 Hyoscyamus and its preparations, on the basis of hyoscyamus alkaloids — 0.073 0.22 Lobelia and its preparations, on the basis of the crude drug — 130 390 Lobeline and its salts — 2.0 6.0 Magnesium Salicylate — 650 4.0 g Methyl Salicylate 30 — — Methylene Blue — 130 390 Phenacetin — 650 1.95 g Phenazone and compounds thereof — 325 975 Phenol 2.0 32.5 260 Phenylpropanolamine when sold or recommended as an appetite depressent — 0.0 0.0 Phosphorus — 0.0 0.0 Podophyllin 0.0 0.0 0.0 Potassium Chlorate — 325 975 Potassium Chlorate, gargle 2.5 — — Procaine and its salts — — — Proxymetacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.0 0.0 0.0 Salicylamide — 975 2.925 g Santonin — 65 130 Selenium and its compounds 2.5 0.0 0.0 Sodium Chlorate — 325 975 Sodium Fluoride — 0.1 0.1 Sodium Salicylate — 650 4.0 g Squill and its preparations, on the basis of crude drug — 32.5 97.5 Stramonium and its preparations, on the basis of stramonium alkaloids — 0.16 0.65 Strychnine and its salts — 0.0 0.0 Tannic A