Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2014-07-22 and last amended on 2014-05-16. Previous Versions

  •  (1) In this Division, “salicylate product” means a drug that contains

    • (a) a salt or derivative of salicylic acid as a single medicinal ingredient;

    • (b) a salt or derivative of salicylic acid in combination with caffeine;

    • (c) a salt or derivative of salicylic acid in combination with one or more buffering agents or antacids; or

    • (d) a salt or derivative of salicylic acid in combination with caffeine and one or more buffering agents or antacids.

  • (2) No manufacturer or importer shall sell a salicylate product after June 30, 1986 unless it meets the requirements of this Division.

  • (3) No manufacturer or importer shall, until June 30, 1986, sell a salicylate product in a dosage unit other than one mentioned in this Division, unless the salicylate product was legally available for sale in Canada on February 1, 1984.

  • SOR/84-145, s. 4;
  • SOR/85-966, s. 5(E).
  •  (1) Subject to subsections (2) and (3) and section C.09.035, a salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of a salicylate per individual dosage form.

  • (2) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain

    • (a) 500 mg of acetylsalicylic acid, sodium salicylate or magnesium salicylate, or

    • (b) 670 mg of choline salicylate

    per individual dosage form if it has a label that states that it is not a standard dosage unit product.

  • (3) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain

    • (a) two adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains two adult standard dosage units; and

    • (b) three adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains three adult standard dosage units.

  • SOR/84-145, s. 4;
  • SOR/85-966, s. 6.
  •  (1) Subject to subsection (2), a salicylate product in the form of a liquid shall contain one adult standard dosage unit of a salicylate per teaspoon.

  • (2) A salicylate product in the form of a liquid may contain

    • (a) two adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains two adult standard dosage units; and

    • (b) three adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains three adult standard dosage units.

  • SOR/84-145, s. 4.