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U.S. Department of Health and Human Services

Drugs

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Questions and Answers – Important change in concentration for over-the-counter (OTC) liquid acetaminophen marketed for infants

On December 22, 2011, The U.S. Food and Drug Administration (FDA) informed the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) became available at local stores. Until then, liquid acetaminophen marketed for “infants” was only available in 80 mg/0.8 mL or 80 mg/mL concentrations. 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.

FDA has prepared this list of questions and answers to provide an overview of these changes for OTC liquid acetaminophen marketed for infants.

Q1.  What is acetaminophen?
Q2.  Why is there a new concentration of over-the-counter (OTC) liquid acetaminophen marketed for infants available?
Q3.  When will the new concentration (160 mg/5 mL) acetaminophen marketed for infants become available?
Q4. Will the old concentration of liquid acetaminophen marketed for infants (80 mg/0.8 mL and 80 mg/ml) be discontinued once the new concentration is available?
Q5.  What should parents and caregivers do if they still have the old concentration (80 mg/0.8 mL and 80 mg/ml) of liquid acetaminophen marketed for infants in their home medicine cabinet?
Q6.  Can dosing devices from the old and new concentrations of liquid acetaminophen marketed for infants be interchanged?
Q7.  Now that there is a liquid acetaminophen available in the 160 mg/5 mL concentration for children between the ages of 2 to 12 years old, how do parents and caregivers tell the difference between the products for younger and older children?

Q1.  What is acetaminophen?

A.  Acetaminophen is the generic name of a drug found in many over-the-counter (OTC) products.   

Acetaminophen as a single active ingredient in OTC products is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache.

Q2.  Why is there a new concentration of over-the-counter (OTC) liquid acetaminophen marketed for infants available?

A.  Single ingredient OTC liquid acetaminophen marketed for infants had been available in 80 mg/0.8 mL and 80 mg/mL concentrations, while the single ingredient OTC liquid acetaminophen marketed for children had been available in a 160 mg/5 mL concentration. Having two very different concentrations of liquid acetaminophen on the market increased the likelihood for dosing confusion and medication errors involving unintentional overdoses in children. Unintentional overdoses with acetaminophen can lead to liver injury and death.

In order to prevent possible dosing confusion between products with different concentrations of acetaminophen, many (but not all) manufacturers decided to voluntarily change the liquid acetaminophen marketed for infants to make it the same concentration as the product used for older children.

Q3.  When does the new concentration (160 mg/5 mL) acetaminophen marketed for infants become available?

A. Some acetaminophen products marketed for infants with the new concentration (160 mg/5 mL) are already available in stores. The transition to the new concentration started earlier this year.

Q4. Will the old concentration of liquid acetaminophen marketed for infants (80 mg/0.8 mL and 80 mg/ml) be discontinued because a new concentration is available?

A. It will be up to manufacturers to determine whether they will stop making the 80 mg/0.8 mL and 80 mg/mL concentrations of liquid acetaminophen. Therefore, it is important for consumers to carefully read the Drug Facts label on the package to identify the strength, dosage, and directions for use for this product. Consumers should always check with a healthcare professional if they have any questions about medications they are using.

Q5.  What should parents and caregivers do if they still have the old concentration (80 mg/0.8 mL and 80 mg/ml) of liquid acetaminophen marketed for infants in their home medicine cabinet?

A. If not expired, the product is safe and effective is used according to the directions specified on the product label. Consumers and parents/caregivers should always carefully read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen, dosage, and directions for use.  If the dosing instructions provided by your healthcare provider differ from what is on the label, check with a healthcare professional before administering the medication.  

In addition, the new 160 mg/5 mL concentration acetaminophen marketed for infants may be packaged with an oral syringe instead of a dropper. This may be different then an older product found in a medicine cabinet. Do not mix and match dosing devices. It is important to understand there are differences between measuring devices.  Only the dosing device provided with the product purchased to measure that product should be used to measure that product.

Q6.  Can dosing devices from the old and new concentrations of liquid acetaminophen marketed for infants be interchanged?

A.  No. Dosing devices sold with different products should never be interchanged. Droppers measure different volume of medicine compared to oral syringes. Using a dropper to measure the new concentration acetaminophen marketed for infants would result in an incorrect volume of administered medicine.  It is important to use the dosing device that comes with acetaminophen product you are using.  Never mix and match dosing devices.

Q7. Now that there is a liquid acetaminophen available in the 160 mg/5 mL concentration for children between the ages of 2 to 12 years old, how do parents and caregivers tell the difference between the products for younger and older children?

A.  Although the product packaging will vary, liquid acetaminophen marketed for younger children will typically state “Infant Acetaminophen for children 2-3 years,” while liquid acetaminophen marketed for older children will typically state “Children's Acetaminophen Ages 2-11.”  Always check the Drug Facts label to ensure you are selecting the appropriate product based on the age and weight of your child.