FDA Sets New Limits for Prescription Combination Products With Acetaminophen

To avoid the risk of "severe liver injury," the Food and Drug Administration (FDA) wants manufacturers of prescription combination products containing acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. Manufacturers also will have to update warning labels on these products to alert consumers about the potential risks.

Acetaminophen, better known as Tylenol, its most popular brand name, is a pain reliever and fever reducer sold over the counter (OTC) as well as in prescription products in combination with other ingredients, such as codeine (Tylenol & Codeine), oxycodone (Percocet) and hydrocodone (Vicodin). The FDA action affects prescription products only, not OTC medications.

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Published In: Administrative Agency Updates, Consumer Protection Updates, Health Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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