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The branded cough and cold medicines that are being voluntarily withdrawn are: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:5/26/2016)... ... 2016 , ... In 1980, Bill Howe opened AM/PM Sewer and Drains as ... vision to grow the company was built on a simple mission of providing qualified ... training and customer service. Over 35 years later, Bill Howe remains one of the ...
(Date:5/26/2016)... ... May 26, 2016 , ... TopConsumerReviews.com recently awarded ... products . , High blood pressure affects millions of people worldwide, and many ... can lead to heart disease, stroke, kidney disease, and hardening of the arteries. ...
(Date:5/26/2016)... ... 26, 2016 , ... Bunion Bootie is a great option for ... save. For a limited time only (offer expires May 31, 2016) customers can save ... by using the promo code "Memorial" at checkout. The more Bunion Booties purchased, the ...
(Date:5/25/2016)... ... May 25, 2016 , ... “We ... Managing Partner at HealthScape Advisors. “Brad brings significant experience advising healthcare provider clients ... system accelerates with the implementation of MACRA, we believe that continuing to add ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... ... in Central Michigan, has produced another video highlighting one of the many supplemental ... Arts class. Sensei Ed Taylor, a 5 th Degree Black Belt in the ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... 24, 2016 ARANZ Medical  Ltd ... healthcare sector, has been named the Coretex Hi-Tech Emerging Company ... Dr Bruce Davey , CEO of ARANZ ...  It,s really good to be recognised for the work we ... are used in 35 countries around the world from Sub-Saharan ...
(Date:5/24/2016)... 2016 The innovator of ... , s first dual therapy stent, introduces catheters ... OrbusNeich, a global company specializing in the provision ... include products to treat peripheral artery disease. The JADE™ ... devices for lower limb and arteriovenous (AV) fistula intervention. ...
(Date:5/24/2016)... -- Dutch surgeons have launched a ground-breaking medical app ... treat patients on a global scale. Medical professionals from ... and the US have already signed up for the ... a totally secure environment. Education  "Imagine a ... with a surgeon at Harvard to treat a bomb victim via ...
Breaking Medicine Technology: