FDA issues draft guidance on pediatric acetaminophen products
SILVER SPRING, Md. — The Food and Drug Administration earlier this month issued draft guidance with several recommendations for manufacturers of acetaminophen products, designed to help minimize the risk to consumers of liver damage associated with the use of pediatric liquids containing acetaminophen.
"FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion," the agency noted in its announcement. "These recommendations apply to both single ingredient and combination ingredient OTC liquid oral drug products that are labeled for use by children under 12 years of age and contain acetaminophen."
According to the Acetaminophen Awareness Coalition, more than 50 million Americans use a medicine that contains acetaminophen — found in more than 600 different over-the-counter and prescription medicines including pain relievers, fever reducers, sleep aids and numerous cough, cold and flu medicines — each week.
Among the recommendations made by FDA:
All single-ingredient acetaminophen oral liquids for pediatric use should have a concentration of 160 mg acetaminophen per 5 mL;
For single-ingredient acetaminophen oral liquids, the statements “160 mg/5 mL” or “160 mg per 5 mL” should be prominently presented on the principal display panel of the container label and carton labeling immediately below or to the right of the active ingredient name (i.e., acetaminophen) and in the same font size as the active ingredient name;
The PDP should clearly indicate the age range and units of age (e.g., months or years) as stated in the Drug Facts Panel under the heading “Directions”;
The dosing directions in the Drugs Facts label should be provided only in milliliters (mL); and
The product package should include an appropriate dosage delivery device, such as a calibrated and labeled oral syringe or dosing cup that's calibrated in millileters (mL).
The Acetaminophen Awareness Coalition, a diverse group of leading health, healthcare provider and consumer organizations, formed the Know Your Dose campaign to educate consumers about safe acetaminophen use in order to prevent liver damage.
