Navigation Links
Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines
Date:10/11/2007

- Potential misuse of these infant medicines, not product safety, is

driving the voluntary withdrawal - This withdrawal does not affect cough and cold medicines for children age

2 and older - Further evaluation of these oral cough and cold medicines for infants and children will occur at the October 18 and 19 FDA advisory committee meeting

WASHINGTON, Oct. 11 /PRNewswire/ -- The Consumer Healthcare Products Association (CHPA) on behalf of the leading makers of over-the-counter cough and cold medicines today announced voluntary market withdrawals of oral cough and cold medicines that refer to "infants." The voluntary withdrawal affects only these "infant" oral medicines, not those intended and labeled for use in children age two and older.

(Photo: http://www.newscom.com/cgi-bin/prnh/20071011/NYTH021 )

"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda A. Suydam, D.P.A, president of CHPA. "The reason the makers of over-the- counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."

The branded cough and cold medicines that are being voluntarily withdrawn are:

-- Dimetapp(R) Decongestant Plus Cough Infant Drops

-- Dimetapp(R) Decongestant Infant Drops

-- Little Colds(R) Decongestant Plus Cough

-- Little Colds(R) Multi-Symptom Cold Formula

-- PEDIACARE(R) Infant Drops Decongestant (containing pseudoephedrine)

-- PEDIACARE(R) Infant Drops Decongestant & Cough (containing

pseudoephedrine)

-- PEDIACARE(R) Infant Dropper Decongestant (containing phenylephrine)

-- PEDIACARE(R) Infant Dropper Long-Acting Cough

-- PEDIACARE(R) Infant Dropper Decongestant & Cough (containing

phenylephrine)

-- Robitussin(R) Infant Cough DM Drops

-- Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant

-- Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant Plus Cough

-- TYLENOL(R) Concentrated Infants' Drops Plus Cold

-- TYLENOL(R) Concentrated Infants' Drops Plus Cold & Cough

This voluntary withdrawal does not affect medicines intended for children age two and older. CHPA and its member companies have put forth recommendations to the U.S. Food and Drug Administration (FDA) to strengthen the labels on all oral OTC children's cough and cold medicines from "ask a doctor" before using to "do not use" in children under two years.

CHPA made these recommendations to the FDA in preparation for a joint FDA advisory committee meeting on October 18 and 19. These recommendations, as well as several additional recommendations, including those proposed by FDA review staff, will be explored further at this meeting.

"These medicines are -and always have been- safe at recommended doses," Suydam said. "These voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children's symptoms. But as with all medicines, it's important that parents read over-the-counter medicine labels carefully, use these medicines only as directed, and store them safely out of the reach of children."

CHPA will be launching a major, multi-year national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse, and pharmacist organizations.

More information about the voluntary withdrawal can be found at http://www.OTCSafety.org.

CHPA is the 126-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.

Contacts: Elizabeth Funderburk and Virginia Cox

202.429.9260

E. Funderburk cell: 202.256.5677


'/>"/>
SOURCE The Consumer Healthcare Products Association
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Researchers identify the early makers of Neonatal Sepsis
2. Epilepsy Patients Could Benefit From Pacemakers
3. Withdrawal Notice Issued For Older Pacemakers Due To Malfunctioning of the Device
4. Stem Cells Could Replace Electronic Pacemakers
5. Lawmakers alerted on new tobacco control policies by research team
6. Chocolate makers to be health wise and urge consumers to be too!
7. Drug Makers Banned From Providing Gifts To Doctors
8. Lawsuit Against Sunscreen Makers For False Claims of Protection Against Skin Cancer
9. Sensing The Health Hazard MP3 Makers Tone Down The Volume
10. Reliability of Pacemakers and Defibrillators to be Improved
11. Food Makers Pressurized to Reduce Salt
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ... April 29, 2016 , ... Our bodies are bombarded daily by ... and deal with these stressors is to adopt a more healthful diet, but too ... Risa Groux, a certified Holistic Nutritionist and the creator of the Newport Beach Cleanse ...
(Date:4/29/2016)... CA (PRWEB) , ... April 29, 2016 , ... ... advocating optimistic healthcare awareness and author of best seller "LOVE, MEDICINE and MIRACLES") ... Radio Monday, May 2, 2016 and podcasted thereafter . Dr. Bernie Siegel, ...
(Date:4/29/2016)... ... 29, 2016 , ... Coast Dental Fort Stewart is celebrating its grand opening ... the Exchange Furniture Mall at 112 Vilseck Road in Fort Stewart. There will be ... attendees will have the opportunity to meet general dentists Thomas Richards, DDS, and Josh ...
(Date:4/29/2016)... ... April 29, 2016 , ... The Wharton ... $30,000 Perlman Grand Prize of the 2016 Wharton Business Plan Competition —as ... People’s Choice Award, and the Committee Award for Most ‘Wow Factor,’ making them ...
(Date:4/29/2016)... ... April 29, 2016 , ... The Gluten-Free Certification ... pleased to announce the launch of the GFCP Scoop in response ... The purpose of the GFCP Scoop site is to keep the ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... April 27, 2016 Oasmia ... developer of a new generation of drugs within ... survival results for Paclical/Apealea in the Phase III ... with epithelial ovarian cancer. These preliminary results showed ... combination with carboplatin versus Taxol in combination with ...
(Date:4/27/2016)... FRANCISCO , April 27, 2016 ... expected to reach USD 2.06 billion by 2022, ... Research, Inc. Increasing consumer awareness towards a healthy ... the next seven years.      (Logo: ... diet intake coupled with rising health treatment expenditure ...
(Date:4/26/2016)... 26, 2016 Diplomat Pharmacy, Inc. (NYSE: DPLO) ... Hagerman , Pharm D., to Vice President of Education ... Diplomat, Hagerman will continue to lead and oversee Diplomat ... custom education and training to Diplomat employees and external ... Diplomat University also houses the quality assurance department, which ...
Breaking Medicine Technology: