August 7, 2015
After ongoing concern regarding potential overdose in OTC pediatric oral liquid drug products containing acetaminophen, FDA announced the availability of a final guidance earlier this week. Published in the Federal Register on Wednesday, August 5th, the document is intended to help drug manufacturers, packagers, and labelers minimize the risk of liver damage related to acetaminophen use in pediatric oral liquid OTC products.
The guidance provides recommendations regarding acetaminophen concentration, carton labeling, and packaging of the products, encouraging safer use of the products by minimizing risk of overdose due to medication errors and/or accidental ingestion. These recommendations apply to both single-ingredient and combination-ingredient products (unless otherwise stated in the guidance) and include recommendations on:
Per the guidance, all single – ingredient products should have a concentration of 160 mg acetaminophen per 5 mL, which should be clearly stated on the container label and carton labeling either immediately below or to the right of the name of the active ingredient. In addition, the guidance also outlines the following recommendations:
TAGS: Agency Alerts
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