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Regulatory Focus™ > News Articles > Canada: New Safety Labeling Guidance for Aspirin Products

Canada: New Safety Labeling Guidance for Aspirin Products

Posted 31 July 2012 | By Ansis Helmanis

Newly proposed safety-related revision from Canadian regulators will apply to acetylsalicylic acid (ASA)-containing products, and contains proposed limits for over-the-counter (OTC) use.

The product, more commonly referred to as aspirin, is increasingly found in combination products containing, for example, codeine and caffeine.

The draft proposal responds to adverse event reports concerning overdoses from products containing ASA, as well as risks to infant health posed by codeine use by nursing mothers. The draft guidance does not apply to products used by children under 12 years of age or for products used for cardiovascular protection or stroke prevention.  The deadline for comments is 27 September 2012.

Read more:

Health Canada - Release of Draft Guidance Document: Acetylsalicylic Acid Labelling Standard

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