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FDA Drug Safety Podcast for Consumers: Addition of another concentration of acetaminophen marketed for infants

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On December 22, the Food and Drug Administration issued a Drug Safety Communication titled: Addition of another concentration of acetaminophen marketed for infants.

I am Yolanda Fultz-Morris from F-D-A’s Center for Drug Evaluation and Research.

FDA is urging consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving children the wrong dose of medicine.

A lower concentration of acetaminophen liquid for infants is now available in stores. Previously, liquid acetaminophen marketed for infants has only been available in a stronger concentration. But now both concentrations are available. FDA is concerned that infants could be given too much or too little of the medicine if the different concentrations of acetaminophen are confused.

Read the Drug Facts label on the package to identify the correct dosing amount for the concentration you have. To recognize the new version of infant acetaminophen, look for this concentration on the package: 160 mg per 5 mL. To recognize the old version of infant acetaminophen, look for this concentration on the package: 80 mg per 0.8 mL.

In addition to the change in concentration, the newly available product may be packaged with an oral syringe on the label.

OTC liquid acetaminophen for infants is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache.

Parents and caregivers should:

  • Carefully read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen, dosage, and directions for use.
  • Be aware that there is no dosing amount specified on the medication box for children younger than 2 years of age. If you have a child younger than 2 years old, always check with your healthcare provider before giving the medication. 
  • Use the dosing device provided with the purchased product in order to correctly measure the correct amount of liquid acetaminophen. If you find the measuring device confusing or if you are unsure of how to measure a dose for your infant using the device, contact your healthcare professional.
  • If the dosing instructions provided by your healthcare provider differ from what is on the label, check with a healthcare professional.
  • Do not rely on dosing information provided from other sources such as the Internet, old dosing charts, or family members.

Healthcare professionals should:

  • Ensure that the directions they give to patients specify the concentration and dose they should give their child.
  • Include the concentration on a prescription because there are different concentrations of liquid infant acetaminophen.  

FDA urges healthcare providers and parents to report any adverse events or side effects that may be associated with the use of acetaminophen liquid for infants to us at the FDA’s MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.

 

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