Updated Labelling Information for Acetylsalicylic Acid (ASA) Products

Starting date:
October 17, 2013
Posting date:
October 17, 2013
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Labelling and Packaging
Audience:
General Public
Identification number:
RA-36303

Issue

Health Canada is releasing an updated Labelling Standard for acetylsalicylic acid (ASA) products for use in adults and children aged 12 years and older. It will help Canadians better choose the right pain or fever relief products for their needs, and use them more safely.

The revised standard includes clear warnings and “DO NOT” cautionary statements that are required to appear on package labels, inner panels and inserts, as well as information on side effects and when to consult a doctor or pharmacist.

The required statements include cautions designed to help prevent overdose, as well as warnings for pregnant women, breastfeeding mothers and children, including a statement to help prevent the occurrence of Reye’s syndrome in children. Reye’s Syndrome is a rare, potentially fatal illness reported to be associated with ASA when used to treat chicken pox, cold or flu symptoms in children. It can cause liver and brain damage, and most often affects children and teens recovering from a viral infection. 

Outer and inner labels of all acetylsalicylic acid containing products will be required to have warning statements that include the following:

  • KEEP OUT OF THE REACH OF CHILDREN
  • DO NOT take more than the recommended dose unless advised by your doctor. Use the smallest effective dose
  • DO NOT TAKE if you are in your last trimester of pregnancy.
  • DO NOT GIVE to children and teenagers less than 18 years of age who have chicken pox, cold or  flu symptoms before a physician or pharmacist is consulted about Reye’s Syndrome, a rare serious illness reported to be associated with acetylsalicylic acid

Codeine or caffeine warnings are also required for products that contain codeine or caffeine in addition to ASA. This includes a new warning that nursing mothers should not take ASA products that contain codeine as codeine my cause serious harm to a breastfed baby.

Health Canada reminds consumers that health products should be used only as directed. Always follow label instructions carefully and use the dosing device if one is included.

This updated labelling standard applies immediately to all new products looking to come into the Canadian market. Companies with products already on the market are expected to update their product labels as soon as possible, during their next planned label run.

Labelling standards outline information that companies are required to include on their product labels and packaging, such as information on dose, intended use, directions for use, warnings, and active ingredients. This Acetylsalicylic Acid Labelling Standard updates and replaces the applicable portions of the December 2, 1994 Analgesics Labelling Standard.

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