Food and Drug Regulations

Version of section C.01.029 from 2006-03-22 to 2018-12-21:

  •  (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.

  • SOR/86-93, s. 2;
  • SOR/87-484, s. 2;
  • SOR/88-323, s. 3(F);
  • SOR/90-587, s. 2;
  • SOR/93-468, s. 1.
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