FDA Publishes Draft Guidance for Acetaminophen Warnings

FDA has published a draft guidance for industry, Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use—Labeling for Products That Contain Acetaminophen. The draft guidance is intended to inform manufacturers of certain over-the-counter internal analgesic, antipyretic, and antirheumatic drug products that contain acetaminophen of the circumstances in which FDA intends to exercise enforcement discretion with regard to the liver warning required in the labeling.