Regulatory Roundup: FDA Sets Limits for Acetaminophen in Prescription Combination Products

Jan 20, 2011
By PharmTech Editors

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, according to an agency release dated Jan. 13, 2011. Because of continued reports of liver injury, FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products with black boxes 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.