FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Additional Background Information

Safety Announcement

[12-22-2011] The U.S. Food and Drug Administration (FDA) is informing the public that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at local stores. Until now, 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.

Facts about OTC liquid acetaminophen marketed for "infants"

Used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache.
Acetaminophen is marketed under brand names such as Tylenol, Little Fevers, Triaminic, Infant/Pain Reliever, Pedia Care, Triaminic Infants' Syrup Fever Reducer Pain Reliever and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).
Consult your physician to dose for children under 2.

In addition to this change in concentration, this product may also be packaged with an oral syringe instead of a dropper.

To avoid confusion and the potential for dosing errors, consumers, parents, and caregivers should carefully read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use. Do not depend on banners stating it is a new product to identify different concentrations of liquid acetaminophen. Many products have similar banners.

It is also important to use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Patients and caregivers should contact their healthcare professional if they find the measuring device confusing or are unsure how to measure a dose for a child using the device provided.

Healthcare professionals should make sure to provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to a child.

Figure. Both boxes in this example say "New" on the front, but only one of them contains the new concentration of liquid acetaminophen. Always read the Drug Facts label and dosing instructions and use the measuring device that came with the product.

FDA has prepared a list of questions and answers and has issued a Consumer Update to provide an additional overview of these changes to OTC liquid acetaminophen marketed for infants.

Additional Information for Consumers and Parents/Caregivers

Parents and caregivers should always read the Drug Facts label on the package for the correct dosing, concentration, and directions for use.
If the dosing instructions provided by a healthcare provider differ from what is on the label, parents and caregivers should check with a healthcare professional before administering the medication.
The 160 mg/5 mL liquid acetaminophen marketed for infants may be packaged with an oral syringe instead of a dropper. Parents and caregivers should only use the device provided with the product purchased to measure the drug. Do not mix and match dosing devices.
Parents and caregivers should check with a healthcare professional if they have any questions about the concentration of liquid acetaminophen they have, dosing directions, or how to measure a dose using the dosing device provided with the product.
Consumers should report side effects or medication errors from the use of OTC acetaminophen products to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.

Additional Information for Healthcare Professionals

Another concentration (160 mg/5 ml) of liquid acetaminophen marketed for "infants" is now available in stores. This product is less concentrated than other liquid acetaminophen products marketed for infants. The other products currently available are in 80 mg/0.8 mL and 80 mg/1 mL concentrations.
Healthcare professionals should use their clinical judgment to recommend the most appropriate liquid acetaminophen product for children under the age of 12, and they should counsel caregivers on product differences.
The 160 mg/5 mL acetaminophen marketed for infants may be packaged with an oral syringe instead of a dropper. It is important to use only the dosing device provided with the product. Do not mix and match dosing devices.
The concentration of liquid acetaminophen should be included on a prescription because multiple products with different concentrations are available.
Healthcare professionals should report adverse events or medication errors involving OTC infant acetaminophen products to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.

Additional Background Information

On June 29-30, 2009, a joint meeting of the FDA Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee discussed the issue of over-the-counter (OTC) liquid acetaminophen (for complete safety reviews and background information discussed at this meeting, see the June 29-30, 2009 AC meeting material). A recommendation was made during this meeting to have only one concentration of pediatric liquid acetaminophen available OTC because products with different concentrations can cause dosing confusion among parents and caregivers that may lead to unintentional overdoses in pediatric patients.

Due to dosing errors that occurred with the concentrated acetaminophen formulation (80 mg/0.8 mL or 80 mg/mL), some manufacturers decided to voluntarily change their liquid acetaminophen products marketed for "infants" to the same concentration (160 mg/5 mL) of liquid acetaminophen products labeled for children. However, since this change is voluntary, products with the old concentration of acetaminophen marketed for infants are still available in stores and in medicine cabinets (see Table 1 below). The availability of infant acetaminophen 160mg/5mL began earlier this year.

Table 1. OTC Liquid Acetaminophen Concentration marketed for infants

Available in the Past	Currently Available
80 mg/0.8 mL (dropper)	80 mg/0.8 mL (dropper)
80 mg/mL (dropper)	80 mg/mL (dropper)
	160 mg/5 mL (oral syringe)

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