Food and Drug Regulations (C.R.C., c. 870)

C.01.019.1 Section C.01.019 does not apply in respect of a veterinary health product.

Maintenance of Records

• C.01.020 (1) The manufacturer shall maintain records of the reports and case reports referred to in sections C.01.017 to C.01.019.

• (2) The manufacturer shall retain the records for 25 years after the day on which they were created.

Limits of Drug Dosage

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

    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 Acid	—	150	1 000
    Tetracaine, its salts and derivatives when sold or recommended for ophthalmic use	0.0	0.0	0.0
    Thiocyanates	0.0	0.0	0.0
    Urethane	0.0	0.0	0.0

    Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced.

    Accurate dosagesmay be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets.