Addition of another
concentration of liquid acetaminophen marketed for infants
On
December 22, 2012, the Food and Drug Administration (FDA) announced 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. In addition to
this change in concentration, this product may also be packaged with an oral
syringe instead of a dropper.
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
over-the-counter acetaminophen products to the FDA MedWatch program.
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/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.
- 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.
- 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 over-the-counter infant acetaminophen products to the FDA MedWatch program.
For more information, see the FDA Drug Safety Communication
available at http://www.fda.gov/Drugs/DrugSafety/ucm284741.htm.