EMAIL TO A FRIEND COMMENT

 

FDA Announces Infant Liquid Acetaminophen Potential for Dosing Errors


The FDA announced an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.  However, 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 or 80 mg/mL concentrations of liquid acetaminophen. In addition to this change in concentration, this product may also be packaged with an oral syringe instead of a dropper.

 

The FDA recommends carefully reading the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use.  Use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Healthcare professionals should provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to a child.

 

Acetaminophen is marketed under brand names such as Tylenol, Little Fevers,  Triaminic, Infant/Pain Reliever, Pedia Care, Triaminic Infants’ Syrup Fever Reducer Pain Reliever and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. See the FDA announcement.

 

 

REPRINTS & PERMISSIONS COMMENT