Cough, Cold Drugs Not for Kids Under 4
Voluntary Label Change Says Don't Give Over-the-Counter Pediatric Cough and Cold Medicine to Children Younger Than 4
Oct. 7, 2008 -- Don't use over-the-counter pediatric cough and cold drugs in kids younger than 4.
Leading makers of over-the-counter pediatric cough and cold drugs are
putting that message on the products' labels, according to the Consumer
Healthcare Products Association (CHPA), a trade group for makers of over-the
The label change comes after consulting with the FDA, which has been
reviewing the safety of over-the-counter pediatric cough and cold drugs.
But the FDA didn't order the label change; drugmakers did that voluntarily.
"We support this
voluntary action that's been taken by the industry," Janet Woodcock, MD,
director of the FDA's Center for Drug Evaluation and Research, said today at a
news conference. “Parents should follow, very carefully, the directions on the
package” and not give children multiple products at the same time, says
cough and cold medicines are covered by rules that date back 30 to 40 years,
and modern studies of the drugs – including clinical trials in children -- are
needed, notes Woodock, adding that that process may take several
The issue isn't an ingredient in the drugs, but dosing errors, notes the
CHPA. Pediatric cough and cold drugs are "safe and effective when used as
directed," says the CHPA, adding that dosing errors and accidental
ingestions are "the leading causes of rare adverse events in young
About 7,000 children under 11 go to emergency rooms each year after taking
cough and cold medicines, according to the CDC. Roughly two-thirds of those
occurred after children drank medication while unsupervised, according to the
The goal of the label change is to encourage "the appropriate use of
these medicines," says the CHPA.
The new labels will start showing up on store shelves this year. The CHPA
says there are no plans to take products with the old labels off the shelves
since the FDA hasn't indicated a need to do so.
January, the FDA urged parents and caregivers not to give over-the-counter
cough and cold drugs to kids younger than 2. Drugmakers voluntarily took
over-the-counter infant cough and cold drugs off
the market in
Don't Use Products to Make Kids Sleepy
Don't use over-the-counter pediatric cough and cold drugs containing antihistamines to sedate or
make a child sleepy. Pediatric cough and cold drugmakers are voluntarily adding
language to that effect to the label of products containing certain
The CHPA is also stressing these key points to parents, caregivers, and
health care providers:
- Follow the dosing recommendations exactly and use the measuring device that
comes with the medicine.
- Do not give a medicine only intended for adults to a child.
- Do not use two medicines at the same time that contain the same
- Prevent unsupervised ingestions by keeping all medicines out of the reach
and sight of children.
- Do not use antihistamine products to make a child sleepy.
- Consult a physician or health care professional with questions.