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

C.09.031. (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.

C.09.032. (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.

C.09.033. (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.