FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Postmarket Safety

FDA Limits Acetaminophen in Children’s OTC Liquid Drugs

Aug. 11, 2015

Drugmakers should limit the amount of acetaminophen in pediatric liquid drugs to 160mg/5mL and include a statement highlighting the concentration on the container and labeling to reduce the chance of overdose, the FDA says. 

Product containers should also have a flow restrictor to reduce accidental ingestion, according to final guidance released last Tuesday.

The recommendations — essentially unchanged from a 2014 draft guidance — apply to both single- and combination-ingredient syrups and solutions labeled exclusively for children under 12.

Dosing directions should be provided only in milliliters, the FDA says. If the word “new” is used on the label, a statement specifying what is new about the product — such as directions or delivery device — should be included. The “new” descriptor should be removed after six months.

Manufacturers also need to include an appropriate dosage delivery device, such as a calibrated and labeled dosing cup or oral syringe with the measurement in milliliters. Firms wanting to use a different delivery device should conduct usability studies and discuss this with the FDA. 

If the delivery device isn’t visible at the point of sale, an image depicting it empty or at the lowest dose should appear on the front of the package. Drugmakers should also ensure that the age presented on the label corresponds with that in the directions. 

The guidance is part of broader FDA efforts to combat liver injury associated with all acetaminophen-containing products, both OTC and prescription.

Last summer, the FDA pulled applications for products containing more than 325 mg of the ingredient. That was followed by draft guidance in November calling for warnings of serious skin reactions caused by acetaminophen.

View the final guidance here: www.fdanews.com/08-5-15-OTCOralAcetaminophenGuidance.pdf. — Kellen Owings