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

Regulations are current to 2017-06-05 and last amended on 2017-05-05. Previous Versions

Limits of Drug Dosage

 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 yearsProportion of adult dose
      10 - 14one-half
      5 - 9one-fourth
      2 - 4one-sixth
      under 2 yearsas directed by physician

      TABLE

      Table of Limits of Drug Dosage for Adults

      ItemExternal UseInternal Use
      Maximum LimitMaximum Dosage Unless otherwise stated, doses are in milligrams
      Per centSingleDaily
      Acetaminophen 6504.0 g
      Acetanilide and derivatives (except N-Acetyl-ρ-amino phenol) 65195
      Acetylsalicylic Acid 6504.0 g
      Aconitine, its preparations and derivatives 0.20.10.1
      Adonis vernalis 65195
      Amylocaine, its salts and derivatives when sold or recommended for opthalmic use 0.00.00.0
      Amylocaine Hydrochloride, except when sold or recommended for ophthalmic use 1.00.00.0
      Antimony, compounds of 3.313
      Atropine, Methylatropine, and their salts 1.00.130.44
      Belladonna and its preparations, on the basis of belladonna alkaloids 0.3750.130.44
      Benzene (Benzol)
      Benzocaine 8.0195585
      Beta-Naphthol 195585
      Butacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.00.00.0
      Butacaine Sulphate, except when sold or recommended for opthalmic use 1.00.00.0
      Cadexomer Iodine 0.00.00.0
      Cantharides, cantharidin, and their preparations, on the basis of cantharidin, except blisters 0.030.00.0
      Cantharides, blisters only 0.20.00.0
      Cedar Oil 25.00.00.0
      Chlorbutol (not more often than every 4 hours) 325975
      Choline Salicylate 8705.22 g
      Cinchocaine Hydrochloride, except suppositories 1.00.00.0
      Cinchocaine Hydrochloride, suppositories only 1111
      Colchicine and its salts 0.551.65
      Colchicum and its preparations, on the basis of colchicine 0.270.81
      Croton Oil 10.00.00.0
      Cyproheptadine and its salts—when sold or recommended for the promotion of weight gain0.00.0
      Ephedrine and its salts 1132.5
      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) 0.551.65
      Gelsemium and its preparations, on the basis of the crude drug 16.248.6
      Hydrocyanic (Prussic) Acid as 2 per cent solution 0.062 ml0.31 ml
      Hydroquinone 2.0
      Hyoscine (Scopolamine) and its salts 0.50.3250.975
      Hyoscine aminoxide hydrobromide 0.50.3250.975
      Hyoscyamine and its salts 0.3250.975
      Hyoscyamus and its preparations, on the basis of hyoscyamus alkaloids 0.0730.22
      Lobelia and its preparations, on the basis of the crude drug 130390
      Lobeline and its salts 2.06.0
      Magnesium Salicylate 6504.0 g
      Methyl Salicylate 30
      Methylene Blue 130390
      Phenacetin 6501.95 g
      Phenazone and compounds thereof 325975
      Phenol 2.032.5260
      Phenylpropanolamine when sold or recommended as an appetite depressent 0.00.0
      Phosphorus 0.00.0
      Podophyllin 0.00.00.0
      Potassium Chlorate 325975
      Potassium Chlorate, gargle 2.5
      Procaine and its salts
      Proxymetacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.00.00.0
      Salicylamide 9752.925 g
      Santonin 65130
      Selenium and its compounds 2.50.00.0
      Sodium Chlorate 325975
      Sodium Fluoride 0.10.1
      Sodium Salicylate 6504.0 g
      Squill and its preparations, on the basis of crude drug 32.597.5
      Stramonium and its preparations, on the basis of stramonium alkaloids 0.160.65
      Strychnine and its salts 0.00.0
      Tannic Acid 1501 000
      Tetracaine, its salts and derivatives when sold or recommended for ophthalmic use 0.00.00.0
      Thiocyanates 0.00.00.0
      Urethane 0.00.00.0

      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.

  • SOR/78-422, s. 1;
  • SOR/80-544, s. 3;
  • SOR/84-145, s. 1;
  • SOR/85-715, s. 3;
  • SOR/85-966, s. 2;
  • SOR/88-94, s. 1;
  • SOR/89-229, s. 2;
  • SOR/89-548, s. 1.
 
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