Infant acetaminophen dose concentration varied by manufacturer

After the introduction of less concentrated liquid acetaminophen marketed for “infants,” the FDA is urging consumers to carefully read labels to determine proper dosage of different products in circulation with varying strengths.

An April report from the FDA’s Center for Drug Evaluation and Research found that confusion caused by the different concentrations of over-the-counter liquid acetaminophen for infants and children was causing overdoses in infants, with some dying of liver failure. To avoid dosing errors, major manufacturers changed the liquid acetaminophen marketed for infants (80 mg/0.8 mL or 80 mg/1 mL) to be the same concentration as the liquid acetaminophen marketed for children (160 mg/5mL).

However, because the dose change was voluntary and not all manufacturers adhered to it, products with higher acetaminophen strengths of 80 mg/ 0.8 mL or 80 mg/1 mL are still in circulation beside their reduced-strength counterparts.

“There are still some of store shelves; there is still some in homes and there is still some in distribution,” Carol Holquist, director of the FDA’s Division of Medical Error Prevention and Analysis, said in a press release.

Holquist said if a pediatrician prescribes a 5-mL dose of less concentrated liquid acetaminophen, but caregivers administer a 5-mL dose of the stronger concentration liquid acetaminophen, the child could receive a potentially fatal overdose. However, if the pediatrician prescribes a dose based on stronger concentration acetaminophen and the less concentrated dose is administered, the dose may be insufficient to combat the fever.

To reduce the confusion surrounding products with disparate dose concentrations, the FDA has outlined identifying markers for consumers:

Look for the “Active Ingredient” section of the Drug Facts label printed on the back of an OTC medication package.
If the package reads “160 mg per 5 L” or “160 mg (in each 5 mL),” this is the less concentrated liquid acetaminophen and should come with an oral syringe for measuring the dose.
If the package reads “80 mg per 0.8 mL” or “80 mg per 1 mL,” this is the more concentrated liquid acetaminophen and should come with a dropper for measuring the dose.

The FDA also has instructed caregivers to contact their health care professional if they find the measuring device confusing, are unsure how to measure dosage using the provided device, or if the dosing instructions on the product label differ from instructions given by the health care professional.

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