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FDA Limits Acetaminophen in Prescription Combination Products

Agency caps maximum at 325 mg to reduce risk of liver toxicity (January 14)

The FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.

The agency also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Acetaminophen relieves pain and fever and can be found in both prescription and over-the-counter (OTC) products. It is combined in many prescription products with other ingredients, usually opioids such as codeine (Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin). OTC acetaminophen products are not affected by the FDA’s action.

The elimination of higher-dose prescription combination acetaminophen products will be phased in over 3 years and should not create a shortage of pain medication, the agency says.

Sources: Reuters; January 14, 2014; and FDA; January 13, 2014.

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