Navigation Links
OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions

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 for children 6 months to 2 years of age.  The committees unanimously voted that the new labeling for children 6 months to 2 years of age include the indication for fever reduction. The committees did not support an indication in labeling for children 6 months to 2 years of age for relief of pain; this indication is currently included for children over 2 years of age.

In addition to including fever reduction as an indication for children 6 months to 2 years of age, CHPA strongly urges FDA to include relief of pain as an indication on the OTC label. Pediatricians recommend acetaminophen as a mainstay for the treatment of pain in children under two years, including pain associated with ear infections, sore throat, teething, and minor traumatic conditions. As experts at the FDA meeting discussed today, physicians can continue to recommend these medicines for pain relief in infants.

In addition to the recommendations discussed at the advisory committee, CHPA member companies recently announced voluntary plans to convert all single-ingredient liquid acetaminophen products for children to a single concentration (160 mg / 5 mL), starting in mid-2011, to help make it easier for parents and caregivers to appropriately use these medicines. Products will continue to be clearly labeled as children's and infants' products and will include flow restrictors that will help make it more difficult for children to ingest large amounts of liquid in the event of an accidental unsupervised ingestion. Syringes will be provided with all infants' products (for children age 3 and under) and children's products (2 years old to under 12 years old) will come with dosing cups. The industry is also voluntarily standardizing all dosing devices with consistent and easily visible measurement markings as well as standardizing the unit of measurement 'mL' on dosing charts and devices.  

As we continue these discussions with FDA, CHPA reminds parents and caregivers to always read and follow the label when giving a child any medicine and to properly store medicines up and away from their children. If parents or caregivers have any questions regarding dosing a child, we strongly recommend that they contact their pediatrician or healthcare professional.

Tips for the safe use and safe keeping of medicines include:

  • Always read and follow the label.
  • Only use the medicine that treats your child's specific symptoms.
  • Store ALL of your family's medicines, including products you use every day high up and out of sight from children.
  • Put medicines away—out of reach and out of sight—EVERY time you use them.
  • Always lock the child safety cap completely every time you use a medicine.
  • Always tell children what medicines are, and do not refer to them as candy.
  • Remind houseguests not to put medicines in purses, bags, coats, or other places small children can get into.
  • Keep the poison control helpline number handy, or program it into your phone: 800.222.1222.

CHPA is the 130-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.

SOURCE Consumer Healthcare Products Association
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Findings From Largest Industry Assessment of 510(k) Process to be Released on May 24, 2011
2. Reportlinker Adds Impact of Healthcare Reforms on the Medical Technology Industry
3. BioStorage Technologies, Inc. Brings Together Industry Leaders to Discuss Future Trends and Challenges of Global Biobanking Community
4. Top Industry Professional Joins Aphena as Head of Quality & Regulatory Affairs
5. Pharma Elite to Unveil Latest Industry News/Program Agenda with 70+ Expert Speakers at Exclusive Event: Pharma CI Conference, September 13-14, 2011 in New Jersey
6. OTC Industry Announces Voluntary Transition to One Concentration of Single-Ingredient Pediatric Liquid Acetaminophen Medicines
7. Cetero Research Names 25-Year Industry Veteran James Dixon to Head Quality and Compliance
8. Reportlinker Adds Pharmaceutical Key Trends 2011 - Pharmaceutical Industry Infrastructure Overview: Pharma innovates, diversifies and contains cost in order to grow profits
9. Top Three Healthcare Supply Chain Executives Challenge Industry
10. Medical Device Industry Veteran Angela Horacek Joins AlloSource as VP of Operations
11. Awarepoint to Showcase Industry-leading Real-time Location System (RTLS) at AONE Annual Meeting
Post Your Comments:
(Date:11/30/2015)... Fla. , Nov. 30, 2015   The ... (the Institute) announced today that it has finalized a ... start-up company with technology developed at Florida State University. ... research, and bridges early funding gaps for companies spinning ... research institutions. --> ...
(Date:11/30/2015)... , November 30, 2015 /PRNewswire/ ... --> adds a ... for 2010 - 2015 with comprehensive ... a range of deal types, such ... strategic alliances. ...
(Date:11/30/2015)... -- --> --> According ... Product (Soft Tissue, All Tissue, Dental Welding Lasers), Application (Conservative ... - Global Forecast to 2020", published by MarketsandMarkets, is expected ... of 5.2% during the forecast period from 2015 to 2020. ... Figures spread through 167 P ages and in-depth TOC ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... 01, 2015 , ... Tympani Inc., announced today that it ... Cisco. This designation recognizes Tympani as having fulfilled the training requirements and program ... the high-end enterprise contact center marketplace. , Ed Kapelinski, President of Tympani stated, ...
(Date:11/30/2015)... ... December 01, 2015 , ... The National Association of ... into its VIP Woman of the Year Circle. She is recognized with this ... exclusively for professional women, boasting 850,000 members and over 200 operating Local Chapters. ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... stressful. At the VA Maryland Health Care System, the Caregiver Support Program ... “Caregivers have a difficult job. Seventy-four percent report that their role as ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... dermatology, is proud to announce that its ThermiRFR temperature controlled radiofrequency platform has ... an innovative multi-application radiofrequency platform which uses temperature as a clinical endpoint. ...
(Date:11/30/2015)... , ... November 30, 2015 , ... ... fun atmosphere for Halloween festivities, the Word of Life Christian Church of Flint, ... game, and featuring a giant 1.25 ton pile of candy dubbed “Candy Mountain”. ...
Breaking Medicine News(10 mins):