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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

FDA Drug Safety Communication Liquid Acetaminophen for Infants

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As we head into cold and flu season, liquid acetaminophen can be a real lifesaver for parents of infant children. But be alert: the FDA announces that local stores can now sell an additional concentration of this drug over the counter.

According to the FDA press release, until now, the only concentration of liquid acetaminophen available for infants was at a concentration of 80mg/0.8 mL or 80 mg/mL. The new concentration that is now available is 160mg/5mL. These new concentrations are sold under the brand names Tylenol, Little Fevers, Triaminic Infants’ Syrup Fever Reducer Pain Reliever as well as a number of store brands.

The FDA wants to make sure that parents and caregivers are aware of this new concentration available because it means that the dosage amount has changed. It is more important than ever that caregivers read the Drug Facts label and carefully follow the directions for use, in particular the recommended dosages. As the press release demonstrates, it isn’t always easy to tell quickly just from the packaging what concentration level you are purchasing. So, always read the enclosed information carefully.

In addition to the new concentrations available, the liquid acetaminophen also is packaged with an oral syringe instead of a dropper. This too changes the way parents and caregivers administer the medication. Since dosage levels are different, it is important for those individuals to make sure they understand the new measuring device.

As is always the case if parents and caregivers have questions about medicating infant children, they should contact a physician who can provide dosage information.