Background: The Consumer Healthcare Products Association (CHPA), an
association that represents most of the makers of nonprescription over-the-
counter (OTC) cough and cold medicines in children, recently announced that its
members are voluntarily modifying the product labels for consumers of OTC cough
and cold medicines to state “do not use” in children under 4
years of age. Additionally, the manufacturers are introducing new child-resistant
packaging and new measuring devices for use with the products.
The U.S. Food and Drug Administration supports the voluntary actions by CHPA
members to help prevent and reduce misuse and to better inform consumers about
the safe and effective use of these products for children. The FDA continues to
assess the safety and efficacy of these products and to revise its OTC monograph
(list of approved ingredients and amounts) for these medicines. Although this new
labeling is inconsistent with the current monograph, FDA will not object, under the
circumstances presented here, to the new label modification stating “do not use in
children under 4,” which reflects a more restrictive use of the drugs in children.
The steps that are being taken by CHPA will not affect the availability of the
medicines, but this voluntary action will result in a transition period where the
instructions for use of some OTC cough and cold medicines in children will be
different from others. FDA does not typically request removal of OTC products
with previous labeling from the shelves during a voluntary label change such as
this one. Therefore, some medicines will have the new recommendation “do not
use” for children under 4 years of age, while others will instruct that they not be
used for children under 2 years of age. If parents or caregivers have or purchase a
product that does not have the voluntarily-modified labeling, FDA recommends
that they should adhere to the dosage instructions and warnings on the label that
accompanies the medication. They should not, under any circumstances, give
adult medications to children. If parents or caregivers have questions or are just
not sure about how to use a product, they should consult with their doctor or
FDA is proceeding with its rulemaking process to update the existing OTC
monograph for cough and cold products for children, and will consider input from
the recent hearing of Oct. 2. The rulemaking process affords additional
opportunity for the submission of data and public comment. Until all these issues
are resolved, FDA continues to recommend to parents and caregivers the following:
- Do not give children medications labeled only for
- Talk to your healthcare professional if you have any
questions about using cough or cold medicines in children.
- Choose OTC cough and cold medicines with child-resistant
safety caps, when available. After each use, make sure to close the cap
tightly and store the medicines out of the sight and reach of children.
- Check the “active ingredients” section of the DRUG FACTS
label of the medicines that you choose. This will help you understand
what symptoms the “active ingredients” in the medicine are intended to treat.
Cough and cold medicines often have more than one active ingredient (such as an
antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain
- Be very careful if you are giving more than one medicine to
a child. If you are giving more than one medicine to a child make sure
that they do not have the same type of “active ingredients.” If you use two
medicines that have the same or similar active ingredients, a child could get too
much of an ingredient and that may hurt your child. For example, do not give a
child more than one medicine that has a decongestant.
- Carefully follow the directions for how to use the medicine in
the DRUG FACTS part of the label. These directions tell you how much
medicine to give and how often you can give it. If you have a question about how
to use the medicine, ask your pharmacist or your doctor. Overuse or misuse of
these products can lead to serious and potentially life threatening side effects
such as rapid heartbeat, drowsiness, suppression of the respiratory system,
seizures and other adverse events.
- Only use measuring devices that come with the medicine or
those specially made for measuring drugs. Do not use common household
spoons to measure medicines for children because household spoons come in
different sizes and are not meant for measuring medicines.
- Understand that using OTC cough and cold medicines does
not cure the cold or cough. These medicines only treat your child’s
symptom(s) such as runny nose, congestion, fever and aches and do not shorten
the length of time your child is sick.