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FDA Wants Clearer Labels on Child Acetaminophen


October 7, 2014 — The FDA has issued voluntary recommendations (PDF) aimed at reducing the number of liver injuries in children who are given over-the-counter liquid acetaminophen.

The FDA has already taken several actions, such as reducing the amount of acetaminophen in prescription drugs to 325-mg per tablet.

In 2011, manufacturers standardized the dose of acetaminophen in products intended for children and infants to 160-mg per 5-mL. Recently, consumer advocates have called on the FDA to make labels on over-the-counter acetaminophen products clearer to help caregivers provide accurate doses for children.

Examples of FDA recommendations include:

  • All acetaminophen products intended for children should have a concentration of 160-mg/5-mL, and this information should be prominently displayed on the front panel.
  • The age range (e.g., months or years) for intended use of the product should be included on the principal display panel.
  • Pictures of any child on the display panel should be representative of the intended patient population.
  • Drug Facts should include dosing in milliliters only.
  • A picture of an empty, appropriate drug delivery device should be pictured on the lower half of the principal display panel. These devices include calibrated and labeled oral syringes or dosing cups. The FDA does not recommend droppers because it is hard to measure an accurate dose.
  • For a pediatric dosing chart, click here.


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