Final Guidance: Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen


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:

  • Product Concentration,
  • Label & Labeling, and
  • Drug Delivery.

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:

  • The use of recommended age range should match the age range that is stated on the Drug Facts label under “Directions”.
  • Any images that are included on the packaging should be consistent with the stated age(s) in the “Directions” section of the Drug Facts label.
  • The word “new” should only be used to state specifically what is new about the product. Additionally, statements about “new” features should not appear for more than six months.
  • Appropriate dosage delivery device should be included in the product package (i.e. calibrated and labeled oral syringe or dosing cup).
  • If the included dosage delivery device is not clearly visible at point-of-sale, there should be an image of the delivery device on the lower half of the PDP. Furthermore, the delivery device may appear empty of at the lowest labeled dose.
  • Dosing directions should only be stated in mL on the Drug Facts label and the included dosage delivery device should be expressed only in mL.
  • If a dosage delivery device other than a syringe or an oral cup is being provided, usability studies should be conducted before the device is introduced to the market.
  • “Firms are encourages to discuss innovative containers/packaging features with FDA before introduction into the market.”

The Weinberg Group can help ensure that your product is in compliance with all of the FDA’s recommendations and regulations. We have an excellent track record of working with our clients to achieve a successful outcome with FDA, and we do this using our unique approach that combines a deep scientific knowledge with extensive regulatory experience. To learn more about our innovative technique and how we can help you with all of your FDA needs, email us here.