Updated Labelling Information for Acetylsalicylic Acid (ASA) Products

(firmenpresse) - OTTAWA, ONTARIO -- (Marketwired) -- 10/17/13 -- Health Canada is releasing an updated 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. 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:

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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Contacts:
Media Inquiries:
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866-225-0709

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Bereitgestellt von Benutzer: Marketwired
Datum: 17.10.2013 - 14:52 Uhr
Sprache: Deutsch
News-ID 306842
Anzahl Zeichen: 0

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OTTAWA, ONTARIO

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Government & Administration

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