To make dosing safer and easier PediaCare® Infants Fever Reducer / Pain Reliever Drops with Acetaminophen will transition to a less concentrated formulation. PediaCare® Infants Fever Reducer Pain Reliever Oral Suspension will have the same concentration of the active ingredient, acetaminophen, as the PediaCare® Children’s Fever Reducer / Pain Reliever.

The infants product will also contain a special dosing syringe for even more accurate dosing, as well as a flow restrictor on the bottle to minimize the risk of accidental ingestions by children.

PediaCare® Infants Fever Reducer Pain / Reliever Drops With Acetaminophen is the only PediaCare® product affected.

PediaCare® Infants Fever Reducer Pain Reliever Drops With Acetaminophen (0.5 fl. oz. and 1 fl. oz.) will be discontinued and replaced with the new concentration, PediaCare® Infants Fever Reducer / Pain Reliever Oral Suspension With Acetaminophen (2 fl. oz.). This voluntary transition will begin during the summer of 2011 and go through early 2012.

We’re doing it to make dosing safer and avoid potential confusion. This is part of an industry-wide initiative to transition to the same single concentration (160 mg/5 mL) for all single-ingredient OTC pediatric liquid acetaminophen products.

There may be a time period when products with different concentrations of acetaminophen will be available on store shelves, and parents and caregivers might have both in the medicine cabinet. Caregivers should always follow the dosing directions on the package they are using, and ask a healthcare professional if they have any questions about dosing instructions.

Click here for complete drug facts for PediaCare® Infants Fever Reducer / Pain Reliever Oral Suspension

PediaCare® Infants Fever Reducer / Pain Reliever Oral Suspension With Acetaminophen (2 fl. oz.) is intended for children 3 years and younger, and the directions on the package label will include dosing instructions for children within this age range. The directions will still instruct parents and caregivers with children over 3 years of age to use PediaCare® Children’s Fever Reducer / Pain Reliever Oral Suspension With Acetaminophen.

PediaCare® Infants Fever Reducer / Pain Reliever Oral Suspension With Acetaminophen (2 fl. oz.) will be available for children 3 years of age and younger.

As with any medication, parents and caregivers should consult a healthcare professional before use if they have any questions about PediaCare® products.

No, this is not a recall, but a voluntary change as part of an industry-wide initiative. Other manufacturers will also be transitioning to the same single concentration (160 mg/5 mL). The decision was made to prevent possible dosing confusion between products with different concentrations of acetaminophen.

Acetaminophen, the only medicine in PediaCare® Fever Reducer / Pain Reliever 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. Acetaminophen is generally recognized as safe for these uses in children when used as directed. For children age 3 and under, use PediaCare® Infants Fever Reducer / Pain Reliever Oral Suspension With Acetaminophen. For children age 2 and older, you can use PediaCare® Children Fever Reducer / Pain Reliever Oral Suspension With Acetaminophen. The only difference between these two products is the dosage device.

PediaCare® Infants Fever Reducer / Pain Reliever products are safe and effective when used as directed on the package.

Click here for complete drug facts for PediaCare® Infants Fever Reducer / Pain Reliever Oral Suspension

PediaCare® Infants Fever Reducer / Pain Reliever Drops With Acetaminophen will remain on store shelves until retailers begin carrying the less concentrated formula.

No. It is very important to choose a product that’s appropriate for your child’s age. While both products contain the same active ingredient and strength, parents should carefully follow the dosing instructions on the label and use the dosing device provided with that product only.

The Food and Drug Administration prepared a list of 10 ways to be sure you’re giving your child the right medicine and the right amount. Always read the label and ask a doctor if you have any questions.

For more information, please visit http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm133419.htm.