WASHINGTON, May 18, 2011 /PRNewswire-USNewswire/ — The Consumer
Healthcare Products Association (CHPA), representing makers of
over-the-counter (OTC) single-ingredient acetaminophen medicines
for children, applauds the U.S. Food and Drug Administration (FDA)
efforts to help parents and caregivers give their children the
right amount of medicine. Today, the FDA’s Nonprescription Drugs
Advisory Committee and Pediatric Advisory Committee recommended
enhancing the labels of all OTC single-ingredient pediatric
acetaminophen products. If FDA acts on these recommendations,
the revised labels would include:
- Dosing instructions for children between ages 6 months to 2
years of age, based on weight and age; and - Dosing instructions by weight (as well as age) on the Drug
Facts label for all children’s single-ingredient acetaminophen
medicines.
“The manufacturers of pediatric acetaminophen products support
the FDA advisory committee’s recommendations to give parents and
caregivers more accurate and detailed dosing information where it
is needed – directly on the Drug Facts label,” said Scott M.
Melville, president & CEO of the Consumer Healthcare Products
Association. “The advisory committee unanimously recognized that
providing parents and caregivers information on how to dose by
weight and how to dose for children 6 months to 2 years of age will
help reduce dosing confusion. These recommendations are consistent
with our members’ longstanding commitment to provide parents and
caregivers with devices and information needed to help ensure
children receive accurate dosing of these safe and effective
medicines.”
In a formal vote, the joint committees unanimously voted in
support of the addition of weight-based dosing for children ages 2
to 12. The joint committees unanimously voted that the
pharmacokinetic (PK), safety, and efficacy data support the
addition of new label directions
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