Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

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

Regulations are current to 2020-05-17 and last amended on 2019-12-16. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

Limits of Drug Dosage (continued)

 Notwithstanding paragraph C.01.021(b), the recommended single and daily dosage of a drug

  • (a) intended to be burned and the smoke inhaled may be increased to 10 times the oral dose, and

  • (b) intended for use as suppositories may be increased to 33 1/3 per cent in excess of the oral dose.

  •  (1) Sections C.01.021 and C.01.022 do not apply to

    • (a) a drug sold to a drug manufacturer; or

    • (b) a drug sold on prescription.

  • (2) Paragraph C.01.021(c) does not apply to

    • (a) acetaminophen;

    • (b) acetylsalicylic acid;

    • (c) magnesium salicylate;

    • (d) sodium salicylate; or

    • (e) choline salicylate.

  • (3) Where a drug mentioned in any of paragraphs (2)(a) to (d) is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended

    • (a) that the drug be used as directed by a physician; or

    • (b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours.

    TABLE

    Maximum Dose

    ItemColumn IColumn IIColumn IIIColumn IVColumn VColumn VIColumn VII
    AgeMaximum Children’s Dose (80 mg units) Acetaminophen DropsMaximum Children’s Dose (80 mg units)Maximum Children’s Dose (160 mg units) AcetaminophenMaximum Adult’s Dose (325 mg units)Maximum Single Dose (mg)Maximum Daily Dose (mg)
    111 to under 12 years631.54802 400
    29 to under 11 years52.51.254002 000
    36 to under 9 years4213201 600
    44 to under 6 years31.52401 200
    52 to under 4 years21160800
    61 to under 2 years1.5 or as directed by a physician120600
    74 months to under 1 year1 or as directed by a physician80400
    80 to under 4 months0.5 or as directed by a physician40200
  • (4) Where choline salicylate is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended

    • (a) that the drug be used as directed by physician; or

    • (b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours.

    TABLE

    MAXIMUM DOSE
    Age (Years)Adult Dosage Units (435 mg)Single Dose (mg)Maximum Daily Dose (mg)
    11 to under 121 ½6603 300
    9 to under 111 ¼5502 750
    6 to under 914402 200
    4 to under 6¾3301 650
    2 to under 4½2201 100
    Under 2As directed by physician
  • SOR/84-145, s. 2
  • SOR/90-587, s. 1

 Both the inner and the outer labels of a drug that carry a recommended single or daily dosage or a statement of concentration in excess of the limits provided by section C.01.021 shall carry a caution that the product is to be used only on the advice of a physician.

 The provisions of section C.01.025 do not apply to

  • (a) a drug sold on prescription, or

  • (b) the inner label of a single-dose container.

  •  (1) Where a person advertises to the general public a drug for human use, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug if it

    • (a) contains a drug set out in the table to section C.01.021; and

    • (b) carries on its label

      • (i) a statement of the recommended single or daily adult dosage that results in a single or daily adult dosage of the drug referred to in paragraph (a) in excess of the maximum dosage set out in the table to section C.01.021 for that drug, or

      • (ii) a statement that shows a concentration of the drug referred to in paragraph (a) in excess of the maximum limit set out in the table to section C.01.021 for that drug.

  • (2) Subsection (1) does not apply to products containing

    • (a) acetaminophen;

    • (b) acetylsalicylic acid;

    • (c) choline salicylate;

    • (d) magnesium salicylate; or

    • (e) sodium salicylate.

  • (3) [Repealed, SOR/94-409, s. 1]

  • (4) Where a person advertises to the general public a drug for human use that contains acetylsalicylic acid, the person shall not make any representation with respect to its administration to or use by children or teenagers.

  • SOR/81-358, s. 1
  • SOR/84-145, s. 3
  • SOR/85-715, s. 4(F)
  • SOR/85-966, s. 3
  • SOR/93-202, s. 5
  • SOR/93-411, s. 1
  • SOR/94-409, s. 1
 
Date modified: