In a Guidance to industry document issued August 4, the FDA endorsed the use of flow restrictors for over-the-
counter (OTC) pediatric oral liquid drug products containing acetaminophen. “OTC pediatric oral liquid drug products
containing acetaminophen have been associated with overdoses due to medication errors that resulted in serious
adverse events, including severe liver damage and death, the FDA notes in the Guidance. This guidance is designed
to help “drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver
damage” associated with use of these products.
Specifically, the FDA recommends adopting “container features designed to improve safety by potentially
contributing to more accurate dosing and helping to reduce the incidence and magnitude of accidental
acetaminophen ingestion by children, such as an appropriate flow restrictor contained in the opening of the
immediate container.” “If a flow restrictor is included, it should be attached to the container in a way that prevents
it from being pushed into the bottle or easily removed. Firms are encouraged to discuss innovative
containers/packaging features with FDA before introduction into the market,” the FDA says.
Related: See Know Your Dose.