Health and Fitness

FDA Limits Acetaminophen in Prescription Combination Products; Requires Liver Toxicity Warnings

Agency strategy caps maximum at 325 milligrams to reduce risk of liver toxicity

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Silver Spring, Maryland–(ENEWSPF)–January 13, 2011. The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe…

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