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

Regulations are current to 2016-08-01 and last amended on 2016-06-14. Previous Versions

Analgesics

General

 No manufacturer or importer shall, after June 30, 1986, sell a drug for analgesia that contains a combination of

  • (a) a salt or derivative of salicylic acid with another salt or derivative of salicylic acid or with salicylamide; or

  • (b) acetaminophen with a salt or derivative of salicylic acid or with salicylamide.

  • SOR/84-145, s. 4.

 Each label of a drug that is intended for internal use and contains acetaminophen, salicylic acid or a salt or derivative thereof shall, after June 30, 1986, carry a caution

  • (a) to consult a physician if the underlying condition requires continued use for more than five days; and

  • (b) that it is hazardous to exceed the maximum recommended dose unless advised by a physician.

  • SOR/84-145, s. 4;
  • SOR/86-589, s. 1.

 Each label of a drug that is intended for internal use and contains salicylic acid or a salt or derivative thereof shall after June 30, 1986, carry a warning statement to consult a physician before taking the drug during the last three months of pregnancy or when nursing.

  • SOR/84-145, s. 4.

Acetaminophen

  •  (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.

  • SOR/84-145, s. 4;
  • SOR/90-587, s. 4.
  •  (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  • (3) [Repealed, SOR/90-587, s. 5]

  • SOR/84-145, s. 4;
  • SOR/90-587, s. 5.
  •  (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.

  • SOR/84-145, s. 4;
  • SOR/85-966, s. 4;
  • SOR/86-954, s. 1;
  • SOR/99-441, s. 1.

Salicylates

  •  (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.

  • SOR/84-145, s. 4.
  •  (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.

 A salicylate product that is claimed to be buffered shall provide at least 1.9 milliequivalents of acid neutralizing capacity per adult standard dosage unit of a salicylate.

  • SOR/84-145, s. 4.

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

  • SOR/84-145, s. 4.
 
Date modified: