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FDA Limits Acetaminophan in Prescription Combination Products

Monday, January 17, 2011

The U.S. Food and Drug Administration (FDA) is asking manufacturers of prescription products that contain acetaminophen to limit its amount to no more than 325 milligrams. The FDA is requiring each manufacturer to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.  Over-the-counter acetaminophen products are not affected by this FDA action.

Acetaminophen is a drug that relieves pain and fever. It is combined in many prescription products with other ingredient, usually opioids.  The reason for this FDA action is because of continued reports of liver injury, though most of the cases of severe liver damage occurred in patients who took more than the prescribed dose.

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