New Infant Acetaminophen Concentration Available - Use Caution to Avoid Dosing Errors
December 23, 2011
FDA issued a Drug Safety Communication regarding an additional “infant” liquid acetaminophen concentration (160 mg/5 mL) now available on the market. Those accustomed to using “infant” liquid acetaminophen 80 mg/0.8 mL or 80 mg/mL concentrations may be at risk for dosing errors because products with the new concentration require different amounts of liquid to provide a standard dose to infants. Liquid acetaminophen 160 mg/5 mL is dosed with an oral syringe instead of a dropper.
In June 2009, FDA recommended a single concentration of pediatric acetaminophen products to avoid unintentional overdoses. Following this recommendation, some manufacturers changed their “infant” liquid acetaminophen products (previously 80 mg/0.8 mL or 80 mg/mL) to be the same concentration as the “pediatric” liquid acetaminophen products (160 mg/5 mL). Since not all manufacturers have made this voluntary change, the 80 mg/0.8 mL and 80 mg/mL products are still available in stores, raising concern about dosing confusion.
Liquid acetaminophen is found in many over-the-counter (OTC) products and is labeled to reduce fever and relieve pain due to the common cold, flu, minor sore throat, headache, and toothache. Liquid products containing acetaminophen marketed for infants include Tylenol®, Little Fevers®, Pedia Care®, Triaminic®, as well as many store branded products (eg, Walgreens, CVS, Rite Aid). Underdosing may result in inadequate pain or fever control while overdosing may cause serious illness or death.
Suggestions for consumers include:
- Carefully read the Drug Facts label on the product package and understand the correct dosing, concentration, and directions for use.
- Only use the dosing device supplied in the package and do not interchange dosing devices between different products.
- Consult with your healthcare provider if the dose they recommend is different from the product label.
Suggestions for healthcare professionals include:
- Counsel patients about the various liquid acetaminophen concentrations available on the market.
- Specify the concentration, dose, and volume on the prescription or when recommending an OTC product.
Report any adverse events to the FDA MedWatch Program (www.fda.gov/MedWatch/report.htm or 1-800-FDA-1088). Additional information is available at the following links.
- MedWatch Alert:
- Drug Safety Communication:
- Consumer Update:
- Frequent Questions and Answers:
December 23, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.