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.

Cautionary Statements and Child Resistant Packages

• C.01.028 (1) Subject to subsection (2), the inner and outer labels of a drug that contains

  • (a) acetylsalicylic acid or any of its salts or derivatives, salicylic acid or a salt thereof, or salicylamide, where the drug is recommended for children, shall carry a cautionary statement to the effect that the drug should not be administered to a child under two years of age except on the advice of a physician;

  • (b) boric acid or sodium borate as a medicinal ingredient shall carry a cautionary statement to the effect that the drug should not be administered to a child under three years of age;

  • (c) hyoscine (scopolamine) or a salt thereof shall carry a cautionary statement to the effect that the drug should not be used by persons suffering from glaucoma or where it causes blurring of the vision or pressure pain within the eye;

  • (d) phenacetin, either singly or in combination with other drugs, shall carry the following cautionary statement:

    “CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician.”; or

  • (e) acetylsalicylic acid for internal use shall carry a cautionary statement to the effect that the drug should not be administered to or used by children or teenagers who have chicken pox or manifest flu symptoms before a physician or pharmacist is consulted about Reye’s syndrome, which statement shall also refer to the fact that Reye’s syndrome is a rare and serious illness.

• (2) Subsection (1) does not apply to a drug that is

  • (a) intended for parenteral use only;

  • (b) dispensed pursuant to a prescription; or

  • (c) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations.

• C.01.029 (1) Subject to subsections C.01.031.2(1) and (2), the inner and outer labels of a drug

  • (a) that contains

    • (i) salicylic acid, a salt thereof or salicylamide,

    • (ii) acetylsalicylic acid, or any of its salts or derivatives,

    • (iii) acetaminophen, or

    • (iv) more than five per cent alkyl salicylates,

  • (a.1) that contains nicotine or any of its salts and is a vaping product as defined in section 2 of the Tobacco and Vaping Products Act but that is not referred to in paragraph 2(b) or (c) or section 3 of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act, or

  • (b) that is in a package that contains

    • (i) more than the equivalent of 250 mg of elemental iron, or

    • (ii) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices,

  shall carry a cautionary statement to the effect that the drug should be kept out of the reach of children.

• (2) Subject to subsections C.01.031.2(1) and (2), the inner label and outer label of a drug that is in a package shall carry a cautionary statement, to the effect that there is enough drug in the package to seriously harm a child, if the package contains

  • (a) more than 1.5 g of salicylic acid or the equivalent quantity of any of its salts or salicylamide,

  • (b) more than 2 g of acetylsalicylic acid or the equivalent quantity of any of its salts or derivatives,

  • (c) more than 3.2 g of acetaminophen,

  • (d) more than the equivalent of 250 mg of elemental iron,

  • (e) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices, or

  • (f) in the case where the drug is a vaping product as defined in section 2 of the Tobacco and Vaping Products Act but is not referred to in paragraph 2(b) or (c) or section 3 of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act, 0.1 mg/ml or more of nicotine or the equivalent quantity of any of its salts.

• (3) The cautionary statements required under subsections (1) and (2) shall be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour.

C.01.030 [Repealed, SOR/2003-196, s. 104]

• C.01.031 (1) Subject to section C.01.031.2,

  • (a) no person shall sell a drug described in subsection C.01.029(1) unless

    • (i) where the drug is recommended solely for children, it is packaged in a child resistant package,

    • (ii) where the drug is not recommended solely for children, other than a drug referred to in subparagraph (iii), at least one of the sizes of packages available for sale is packaged in a child resistant package, and

    • (iii) where the drug is a vaping product referred to in paragraph C.01.029(1)(a.1), it is packaged in a child resistant package; and

  • (b) where a drug described in subsection C.01.029(1) is packaged in a package that is not a child resistant package, the outer label shall carry a statement that the drug is available in a child resistant package.

• (2) Subsection C.01.031.2(2) and paragraph C.01.031.2(3)(a) do not apply to a drug referred to in paragraph C.01.029(1)(a.1).