Safety Alerts & Recalls

What does this mean?

Before giving the acetaminophen to infants and children, parents and caregivers need to know whether they have the less concentrated version or the older, more concentrated medication.

Here’s what the FDA wants parents and caregivers to do:

- 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.

If you have any questions about acetaminophen use in infants and children, please follow up with your doctor.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available

The Food and Drug Administration (FDA) is urging consumers to carefully read the labels of liquid acetaminophen (also known by brand name Tylenol) marketed for infants to avoid giving the wrong dose to their children.

A less concentrated form of the medication is arriving on store shelves, and giving the wrong dose of acetaminophen can cause the medication to be ineffective if too little is given or cause serious side effects and, possibly, death if too much is given.

In an attempt to reduce the confusion over different strengths that have been blamed for past overdoses, some manufacturers are making a switch and offering only the less concentrated version for all children.

Until now, liquid acetaminophen marketed for infants has only been available in a stronger concentration that doesn’t require giving the infants as much liquid with each dose.

But right now both concentrations of liquid acetaminophen are available. The FDA is concerned that infants could be given too much or too little of the medicine if the different concentrations of acetaminophen are confused.

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Source: FDA
Publication Date: 2011-12-27
Last Updated: 2011-12-27
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