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

C.09.020. (1) The adult standard dosage unit of acetaminophen shall be 325 mg.

(2) The children’s standard dosage units of acetaminophen shall be 80 mg or 160 mg.

C.09.021. (1) In this Division, “acetaminophen product” means a drug that contains

• (a) acetaminophen as a single medicinal ingredient; or

• (b) acetaminophen in combination with caffeine.

(2) No manufacturer or importer shall sell an acetaminophen product unless it meets the requirements of this Division.

(3) [Repealed, SOR/90-587, s. 5]

C.09.022. (1) Subject to subsections (2) to (4), an acetaminophen product sold in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of acetaminophen per individual dosage form.

(2) An acetaminophen product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain 500 mg of acetaminophen per individual dosage form if it has a label that states that it is not a standard dosage unit product.

(3) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration may contain 325 mg of acetaminophen for immediate release and another 325 mg for subsequent release, if it has a label that states that it is not a standard dosage unit product.

(4) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per individual dosage form.

(5) An acetaminophen product in the form of a liquid that is intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per millilitre of the product.

(6) A package of an acetaminophen product described in subsection (5) shall be accompanied by a measuring device capable of accurately delivering 0.5 mL of the product.

(7) An acetaminophen product in the form of a liquid that is not intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit per teaspoon of the product.

(8) An acetaminophen product in the form of a liquid shall contain one adult standard dosage unit of acetaminophen per teaspoon of the product.

C.09.030. (1) The adult standard dosage unit of a salicylate shall be

• (a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 325 mg; and

• (b) in the case of choline salicylate, 435 mg.

(2) The children’s standard dosage unit of a salicylate shall be

• (a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 80 mg; and

• (b) in the case of choline salicylate, 110 mg.