Draft Guidance Document - Acetaminophen Labelling Standard

The online consultation is now closed. The final guidance is available now. Comments and suggestions received from the consultation on the draft version of the guidance were reviewed and considered in the finalization of this document.

Once finalized, this labelling standard will identify the permitted ingredients, doses, and indications for use for these products, as well as the font size, the directions for use and ingredient-specific warning statements which will be required to appear on the product labels.  The final labelling standard will replace the applicable portions of the December 2, 1994 Analgesics Labelling Standard.  It is anticipated that manufacturers of acetaminophen-containing preparations affected by this labelling standard will be contacted within one year of the adoption of the draft labelling standard to initiate an implementation plan for revisions to existing drug products.

How to Get Involved

This consultation is open for comment starting January, 19, 2009 until March 20, 2009. 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
Finance Building Address Locator 0202B
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

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

Consultation Document: To obtain a copy of the draft guidance document that was consulted upon, please contact Bureau of Gastroenterology Infection and Viral Diseases

Interested parties are encouraged to provide comments and suggestions by March 20, 2009.

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 BGIVD_Enquiries@hc-sc.gc.ca