Draft Guidance Document - Acetylsalicylic Acid Labelling Standard

This draft guidance document was developed as a result of an assessment of acetylsalicylic acid (ASA) product-related adverse reaction reports. The intent is to provide updated information for the safe use and appropriate labelling of ASA products. In particular, this labelling standard includes strengthened safety labelling requirements regarding acetylsalicylic acid overdosing and the risks to infant health posed by codeine use in nursing mothers.

This labelling standard applies specifically to adults and excludes products used by children under 12 years of age or products used for cardioprotection and stroke prevention. This labelling standard identifies the permitted ingredients, doses, indications, directions for use and ingredient-specific warning statements for these products which will be required to appear on their labels. This labelling standard also reflects the safety concerns regarding concomitant use with other drugs containing ASA or other salicylates, or other nonsteroidal anti-inflammatory drugs (for example, ibuprofen, naproxen). Once finalized this Acetylsalicylic Acid Labelling Standard will replace the applicable portions of the December 2, 1994 Analgesics Labelling Standard.

How to Get Involved

This consultation is open for comment starting July 27, 2012 until September 25, 2012. Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

BGIVD_Enquiries@hc-sc.gc.ca

Bureau of Gastroenterology, Infection and Viral Diseases
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Finance Building, Address Locator 0202D1
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

Telephone: 613-941-2566
Fax: 613-941-1183

Consultation Document

Interested parties are encouraged to provide comments and suggestions by September 25, 2012.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact us at Bureau of Gastroenterology, Infection and Viral Diseases