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, 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 and outer labels of a drug that is in a package that 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, or

• (e) 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 there is enough drug in the package to seriously harm a child.

(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.