"Compliments Muscle and Back Pain Relief Regular Strength": Labelling Error May Pose Serious Risks to Children
(firmenpresse) - OTTAWA, ONTARIO -- (Marketwire) -- 12/29/11 -- The issue:
Health Canada is advising Canadians that Vita Health's product, "Compliments Muscle and Back Pain Relief Regular Strength" contains a significant labelling error in the French dosing directions that may pose serious risks to children (less than 12 years of age), if taken by them. According to the product label, this product is for adult use only and should not be administered to children less than 12 years of age. This product is advertised as a muscle relaxant and painkiller.
The current incorrect French label under "Posologie" states "Adultes et enfants de 2 ans et plus" whereas it should read "Adultes et enfants de 12 ans et plus". However, the statement "Ne pas administrer aux enfants ages de moins de 12 ans" appears later on in the same section (See photos below). Health Canada would like to remind consumers that the English dosing directions contain no errors and the label correctly states for "Adults and Children 12 years and older."
Who is affected:
Canadians who have purchased "Compliments Muscle and Back Pain Relief Regular Strength" for use by their children who are less than 12 years of age.
What consumers should do:
What Health Canada is doing:
Vita Health is recalling five affected lots of the product (0K078B27ZI, 0K078B29VL, IA100B2AQH, 1H106B2GVP and 1H106B2HJJ) in the 18 tablet package from the Canadian market. Canadians can be confident that Health Canada is monitoring the voluntary recall by Vita Health. Should additional information be identified, Health Canada will take appropriate action and inform Canadians.
An image of the product "Compliments Muscle and Back Pain Relief Regular Strength" is available at the following address:
Background:
"Compliments Muscle and Back Pain Relief Regular Strength" is advertised as a muscle relaxant and painkiller for the relief of minor pain associated with muscle spasm such as back pain, tense neck muscles and strains and sprains. Each caplet contains 325 mg of acetaminophen and 400 mg of methocarbamol. The maximum recommended daily dose for adults and children 12 years and older is eight caplets.
Ingestion by children less than 12 years of age can result in acetaminophen overdose and may cause serious health consequences including liver damage. Early signs of overdose include nausea, vomiting lethargy and sweating. Liver damage may result in liver failure or death. Abdominal pain may be the first sign of liver damage and may not be apparent for 24 to 48 hours.
For more information:
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.
Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.
How to report side effects to health products:To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a () and send to us using one of these methods:
Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools:
Egalement disponible en francais
Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 29.12.2011 - 14:24 Uhr
Sprache: Deutsch
News-ID 1069112
Anzahl Zeichen: 0
contact information:
Contact person:
Town:
OTTAWA, ONTARIO
Phone:
Kategorie:
Government & Administration
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""Compliments Muscle and Back Pain Relief Regular Strength": Labelling Error May Pose Serious Risks to Children
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