In January of 2008, The Food and Drug Administration issued a public health

advisory saying that over-the-counter cough and cold medications should not be given to children under age 2 because of the possibility of serious and life-

threatening side effects. The FDA is studying what should be done in regards to

these medications and 2- to 11-year-olds.

Over-the-counter cough and cold medicines do not work for children under age 6

and, in some cases, may pose a health risk. The efficacy and risk of such

medications needs to be studied in children. As the AAP has testified: "If a medicine will be used in children, it should be studied in children. Cough and cold medications should not be exceptions to this rule." The labeling needs to reflect what we know: the medications are not effective for children under age 6 and their use, and misuse, could cause serious, adverse side effects.

Currently dosage information for these cough and cold medicines is based on adult experience. But children are NOT little adults and studies show their bodies handle

the medications differently. Because of this it is unclear how great the risk there is

of mis-dosing and overdosing.

Remember, cold symptoms, while annoying and at times uncomfortable, are not dangerous and will go away in time.  Under no circumstances, should these medications be given to very young children. (under 2 years old)

In addition, the following products that were marketed to under 2 year olds have been withdrawn from the shelves:

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

If you have these products in your home and your child is not 2 years of age or older, we recommend discarding the medication or contacting your local pharmacy to inquire about refund options.

Sincerely,

The Center For Advanced Pediatrics

Acetaminophen (Tylenol, Tempra, Liquiprin, Panadol)
Dimetapp
Ibuprofen (Motrin, Advil)
Pediacare Cough & Cold Liquid
Pediacare Cough & Cold Tabs
Pediacare Infant Decongestant Drops
Pediacare Infant Decongestant Plus Cough Drops
Pediacare Night Rest Liquid
Triaminic
Children's Tylenol Cold
Infants' Tylenol Cold Plus Cough