January 13, 2011
FDA limits acetaminophen in prescription combination productsThe FDA is asking manufacturers of acetaminophen (APAP)-containing prescription combination products to limit the amount of APAP to a maximum of 325mg per tablet or capsule because of continued reports of liver injury. Manufacturers will also be required to update labels of all prescription combination APAP products to warn of the potential risk for severe liver injury. The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years and should not create a shortage of pain medication.
Acetaminophen is an analgesic and antipyretic agent indicated for the management of pain and fever. It is combined in many prescription products with other drugs, usually opioids such as codeine, oxycodone, and hydrocodone.
For more information visit www.fda.gov/acetaminophen.