Food and Drug 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.