Food and Drug Regulations

C.01.028 (1) Subject to subsection (2), the inner and outer labels of a drug that contains

• (a) acetylsalicylic acid or any of its salts or derivatives, salicylic acid or a salt thereof, or salicylamide, where the drug is recommended for children, shall carry a cautionary statement to the effect that the drug should not be administered to a child under two years of age except on the advice of a physician;

• (b) boric acid or sodium borate as a medicinal ingredient shall carry a cautionary statement to the effect that the drug should not be administered to a child under three years of age;

• (c) hyoscine (scopolamine) or a salt thereof shall carry a cautionary statement to the effect that the drug should not be used by persons suffering from glaucoma or where it causes blurring of the vision or pressure pain within the eye;

• (d) phenacetin, either singly or in combination with other drugs, shall carry the following cautionary statement:

  “CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician.”; or

• (e) acetylsalicylic acid for internal use shall carry a cautionary statement to the effect that the drug should not be administered to or used by children or teenagers who have chicken pox or manifest flu symptoms before a physician or pharmacist is consulted about Reye’s syndrome, which statement shall also refer to the fact that Reye’s syndrome is a rare and serious illness.

(2) Subsection (1) does not apply to a drug that is

• (a) intended for parenteral use only;

• (b) dispensed pursuant to a prescription; or

• (c) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations.