FDA Recommends Clearer Labels on Children’s Tylenol

October 7, 2014 — The U.S. Food and Drug Administration (FDA) has issued draft guidance (PDF) for over-the-counter pediatric liquid drug products containing acetaminophen.

The FDA is recommending specific labeling and dosage limitations to “avoid confusion and the potential for dosing errors” in over-the-counter products containing acetaminophen that are intended for children under 12.

These recommendations are intended to minimize the risk of acetaminophen-related liver damage. Earlier this year, they removed prescription medications containing over 325-mg of acetaminophen from the market. Infant and children’s acetaminophen dose were standardized to 160-mg/5-mL in 2011.

Recommendations from the FDA include:

• Liquid acetaminophen products for children should have a concentration of 160-mg of acetaminophen per 5-mL. Click here for a pediatric dosing chart.
• The principal display panel should contain information about the age range (e.g., months or years) of intended use for the product.
• Any child in the label should be representative of the patient population age.
• Dosing instructions on the Drug Facts should be provided only in milliliters.
• An image of an appropriate drug delivery device should be included on the lower half of the principal display panel, such as a calibrated and labeled oral syringe or a dosing cup. The use of droppers is discouraged because it is difficult to measure an accurate dose.
• And more