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Oct-11-2007 09:30printcomments

Drug Makers Recall Infant OTC Cold Medicine

The voluntary withdrawal only affects oral infant cough and cold medications.

cold medicines
Salem-News.com

(SALEM, Ore. ) - The Consumer Healthcare Products Association (CHPA), on behalf of the leading makers of over-the-counter (OTC) cough and cold medicines, announced the voluntary withdrawal of oral infant medications from store shelves.

Here are the facts:

The voluntary withdrawal of OTC oral infant cough and cold medicines was initiated by the makers of those medications out of an abundance of caution. This is not a mandatory recall or a safety issue.

Kids’ OTC cough and cold medicines are both safe and effective when used correctly. Rare cases of overdose from misuse, however, have occurred—particularly in infants less than two years of age.

Infants under the age of two are the most vulnerable to the consequences of this misuse.

The voluntary withdrawal only affects oral infant cough and cold medications. It does not affect any other children’s medicines.

OTC pediatric cough and cold medicines affected by this voluntary withdrawal are listed below:

  • Dimetapp® Decongestant Plus Cough Infant Drops
  • Dimetapp® Decongestant Infant Drops
  • Little Colds® Decongestant Plus Cough
  • Little Colds® Multi-Symptom Cold Formula
  • PEDIACARE® Infant Drops Decongestant containing pseudoephedrine)
  • PEDIACARE® Infant Drops Decongestant Cough (containing pseudoephedrine)
  • PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)
  • PEDIACARE® Infant Dropper Long- Acting Cough
  • PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
  • Robitussin® Infant Cough DM Drops
  • Triaminic® Infant & Toddler Thin Strips® Decongestant
  • Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough
  • TYLENOL® Concentrated Infants' Drops Plus Cold
  • TYLENOL® Concentrated Infants' Drops Plus Cold & Cough

Parents can continue to trust and rely on over-the-counter cough and cold medicines for their children, as they have for generations, because these medicines are safe at recommended doses.

As with any medicine, it is important for parents to read the labels carefully, use these medicines only as directed, and make sure to safely store them out of the reach of children.

Labels currently direct parents and caregivers to "ask a doctor" before giving these medicines to children under two. In September 2007, the makers of these medicines recommended to the U.S. Food and Drug Administration that medicine labels have stronger language instructing that parents "do not use" for children under two to prevent incidents of misuse.

Harm from OTC cough and cold medicines is rare and, when it does occur, is almost always the result of misuse (significant overdose or accidental swallowing due to medicine not being properly stored and secured).

As with all medicines, dosing instructions for all over-the-counter remedies must be read and followed carefully. It is important to remember that any medicine can cause harm if taken or used improperly.

Safe use and safekeeping are extremely important. Giving medicine according to label directions is part of the solution; storing it out of the sight and reach of children is part of it, as well.

Because children under age two are the most vulnerable to the harm caused by the misuse of oral, over-the-counter cough and cold medicines, the makers of these medicines have recommended strengthening their labels to state "Do Not Use" for children under two.

This recommendation, as well as others, will be discussed before a U.S. Food and Drug Administration advisory committee on October 18 and 19. FDA asked for the meeting of outside experts to bring the best science to bear on this important issue.

FDA requested analyses and recommendations from its staff of reviewers, but the agency has not and will not take an official position until after it has the opportunity to discuss and examine all the information. FDA has not called for a "ban" on or "recall" of these medicines.

The makers of over-the-counter cough and cold medicines want to ensure that parents and caregivers understand when and how to use these medicines safely.

The safe use of these medicines is our highest priority. We will soon launch a major national educational program to build awareness among parents and other caregivers about how to safely use over-the-counter medicines in children, and, as importantly, when not to use them.
Source: otcsafety.org




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nurse daddy October 18, 2007 6:12 am (Pacific time)

not only does it have to do with mass proportions it also has to do with the immature liver and kidneys. they are unable to metabolize and excrete the drug as well as a child. leading to a build up of the medication in their system. i feel this has been a long time coming


Carla October 12, 2007 7:49 pm (Pacific time)

Mamaoftwo, my husband and I are right there with you in our cough-supressing philosophy for our beloved 5-year-old daughter. :) Let's hear it for a dying breed, parents who actually care about their children... High five, Carla


Neal Feldman October 12, 2007 10:41 am (Pacific time)

"Infants" inder the age of two? How many INFANTS are there OVER the age of two? Personally I consider an infant to be before toddler (walking) but usually even younger (crawling but not cruising). Big surprise mos ODs happen then considering the small mass compared to dosage. But apparently because some folks cannot or will not read and follow directions now parents will be forced to give their kids adult drugs instead, which will have a much higher chance of OD. Great planning guys. Bravo! Ah well...


Mamaoftwo October 11, 2007 2:01 pm (Pacific time)

I know how cold medicine containing pseudoephedrine or phenylephrine makes me feel when I take it, so I have never given it to my children. I might just be paranoid, but I also don't give my kids cough suppressants. I give them expectorants (Guaifenesin) instead as it helps the crud get up and out of their chest, thus making them feel better sooner. Suppressants make the coughing stop temporarily but only masks and seems to prolong the problem. Just my two cents :wink:

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