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

C.01.022 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.

• C.01.024 (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.

  Item	Column I	Column II	Column III	Column IV	Column V	Column VI	Column VII
  	Age	Maximum Children’s Dose (80 mg units) Acetaminophen Drops	Maximum Children’s Dose (80 mg units)	Maximum Children’s Dose (160 mg units) Acetaminophen	Maximum Adult’s Dose (325 mg units)	Maximum Single Dose (mg)	Maximum Daily Dose (mg)
  1	11 to under 12 years	—	6	3	1.5	480	2 400
  2	9 to under 11 years	—	5	2.5	1.25	400	2 000
  3	6 to under 9 years	—	4	2	1	320	1 600
  4	4 to under 6 years	—	3	1.5	—	240	1 200
  5	2 to under 4 years	—	2	1	—	160	800
  6	1 to under 2 years	1.5 or as directed by a physician	—	—	—	120	600
  7	4 months to under 1 year	1 or as directed by a physician	—	—	—	80	400
  8	0 to under 4 months	0.5 or as directed by a physician	—	—	—	40	200

• (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.

  MAXIMUM DOSE
  Age (Years)	Adult Dosage Units (435 mg)	Single Dose (mg)	Maximum Daily Dose (mg)
  11 to under 12	1 ½	660	3 300
  9 to under 11	1 ¼	550	2 750
  6 to under 9	1	440	2 200
  4 to under 6	¾	330	1 650
  2 to under 4	½	220	1 100
  Under 2	As directed by physician

C.01.025 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.

C.01.026 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.

• C.01.027 (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.