The Food and Drug Administration is urging consumers to carefully read the labels of liquid acetaminophen to avoid giving the wrong dose to their infants as it can cause serious side effects and possibly be fatal.

In a statement released Friday, the FDA said it is especially concerned because a less concentrated form of the medication marketed for infants being sold at stores as liquid acetaminophen has only been available in a stronger concentration.

While both concentrations of liquid acetaminophen are in circulation the agency urges parents and caregivers to read the labels before giving the medication so they know what version of the medication they have, the less concentrated or the more concentrated medication in order to give the safe amount of medicine.

Carol Holquist, director of FDA’s Division of Medical Error Prevention and Analysis urged patients to be “very careful when you’re giving your infant acetaminophen.”

The FDA highlighted what parents and caregivers should be doing before giving an infant acetaminophen.

  • Read the Drug Facts label on the package very carefully to identify the concentration of the liquid acetaminophen, the correct dosage, and the directions for use.
  • Do not depend on a banner proclaiming that the product is “new.” Some medicines with the old concentration also have this headline on their packaging.
  • Use only the dosing device provided with the purchased product in order to correctly measure the right amount of liquid acetaminophen.
  • Consult your pediatrician before giving this medication and make sure you’re both talking about the same concentration.

In the past the FDA’s Center for Drug Evaluation and Research (CDER) found that confusion caused by the different concentrations of liquid acetaminophen for infants and children caused overdoses that made infants seriously ill while others died from liver failure.

Holquist explained that if a pediatrician prescribes a 5 mL dose of the less concentrated liquid acetaminophen, but the parents administer a 5 mL dose of the more concentrated liquid acetaminophen, the child can receive a potentially fatal overdose during the course of therapy.

But even if the physician prescribes a dose based on the more concentrated liquid acetaminophen and the less concentrated medication is used, the child might not receive enough medication to fight a fever, she said.

While both boxes and bottles may look the same Holquist advised as follows:

  • Look for the “Active ingredient” section of the Drug Facts label usually printed on the back of an over-the-counter (OTC) medication package.
  • If the package says “160 mg per 5 mL” or “160 mg (in each 5 mL)”, then this is the less concentrated liquid acetaminophen. This medication should come with an oral syringe to help you measure the dose.
  • If the package says “80 mg per 0.8 mL” or “80 mg per 1 mL,” then this is the more concentrated liquid acetaminophen. This product may come with a dropper.