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.
- 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
- Date modified: