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Guidance on OTC Acetaminophen Drugs and Skin Reactions

12/02/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions. It is intended to inform manufacturers, members of the medical and scientific community, and other interested persons that at this time that FDA does not intend to object to the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter drug products bearing a warning as described in the draft guidance alerting consumers that the use of acetaminophen may cause severe skin reactions. To download this guidance, click here. To view this notice, click here.

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