Liquid Acetaminophen Product Dose for Infants Should be Checked for Accuracy, FDA Advises

January 4, 2012 5:53 PM

Food and Drug Administration (FDA) advises consumers to ensure that infants administered liquid acetaminophen products are given the correct dose, as an additional concentration marketed for infants is now available. The new product is less concentrated (160 mg/5 ml) than the prior available concentration of 80 mg /0.8 mL. This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL concentrations of liquid acetaminophen. FDA provides the steps consumers should take to ensure that infants are administered the correct dose in a Safety Announcement. Steps for parents and caregivers include the following:

• Read the Drug Facts label on the package carefully, looking for the concentration of the liquid acetaminophen in mg/mL and reviewing the recommended dosage and directions for use. FDA notes that consumers should not depend on product banners stating that the item is a new product when identifying different concentrations of liquid acetaminophen.
• If the dosing instructions provided by a health care provider differ from what is on the label, parents and caregivers should check with a health care provider before administering the medication.
• Use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Do not mix and match dosing devices.
• Contact the appropriate health care provider with questions, if the measuring device seems confusing or are there are any questions about measuring a dose for a child using the device provided. 

FDA also encourages health care providers to give patients directions that specify the concentration and dose of liquid acetaminophen that should be given to a child.