FDA Limits Acetaminophen Use In Prescription Drugs

Law360, New York (January 13, 2011, 1:23 PM EST) -- The U.S. Food and Drug Administration has ordered makers of prescription drugs containing the painkiller acetaminophen to limit the amount of the ingredient in each tablet to 325 milligrams and add boxed warnings alerting users to the risk of severe liver injury.

In an announcement issued Thursday, the agency also required manufacturers to add boxed warnings to labels for prescription acetaminophen products alerting users to the risk of severe liver injury. The new requirements do not affect makers of over-the-counter drugs containing the ingredient.

Acetaminophen is...
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