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FDA Releases Guidance Document for Pediatric Oral Liquid Drug Products Containing Acetaminophen

September 15, 2015

UNITED STATES  ̶  The U.S. Food and Drug Administration (FDA) has released a guidance document for over-the-counter (OTC) pediatric oral liquid drug products containing acetaminophen, to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of these nonprescription products.

The guidance document provides information on the acetaminophen concentration, container labels, labeling, and packaging of such products, as well as for any associated delivery devices.

Comments on the guidance document are now being accepted at!docketDetail;D=FDA-2014-D-1473