FDA Releases Draft Guidance on Liver Warning for Some Drugs w/ Acetaminophen
A draft guidance is now available on labeling requirements for certain over-the-counter internal analgesic, antipyretic, and antirheumatic drug products that contain acetaminophen, said the Food and Drug Administration (FDA). The draft guidance, entitled “Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic…
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Drug Products for Over-the-Counter Human Use -- Labeling for Products That Contain Acetaminophen,” is intended to inform manufacturers of the circumstances in which the FDA intends to enforce the liver warning requirement for such products. To ensure consideration of comments before the final version of this guidance is released, comments should be submitted by Sept. 4, the FDA said. The draft guidance is available here.