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GUIDANCE DOCUMENT

Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions January 2017

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-1862
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

FDA is informing manufacturers, members of the medical and scientific community, and other interested persons that at this time we do not intend to take action against the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing an allergy warning as described in this guidance (see section III, Discussion and Policy) alerting consumers that the use of acetaminophen may cause severe skin reactions.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-1862.

 
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