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Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen August 2015

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription also known as over-the-counter or OTCpediatric oral liquid acetaminophen drug products. Many of these products are marketed under the OTC conditions stated in FDA’s Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use (the IAAA TFM).2 FDA plans to address portions of the tentative final monograph through the notice and comment rulemaking process. In the meantime, however, to encourage safer use of these products, we are providing recommendations regarding acetaminophen concentration, container labels, carton labeling, and packaging of such products as well as for any associated delivery devices. FDA’s recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion. Unless otherwise specified, these recommendations apply to both single-ingredient and combination-ingredient OTC oral liquid drug products (such as suspensions, solutions, elixirs, and syrups) that are labeled for use in children under 12 years of age and contain acetaminophen. This guidance does not address OTC acetaminophen oral liquid drug products for use in both children and adults or for adults only.

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-1473.

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