Oct. 8, 2008, the Food and Drug Administration (FDA) released a
statement that supports recent voluntary actions by many drug
manufacturers regarding the use of nonprescription, over-the-counter
(OTC) cough and cold products in children.
voluntary actions announced by the Consumer Healthcare Products
Association (CHPA) are intended to help prevent and reduce the misuse
of these products in children and to better inform consumers about
their safe and effective use. CHPA represents most of the manufacturers
of these products.
Members of CHPA have volunteered to
modify the product labels of OTC cough and cold medicines to state "do
not use" in children under 4 years of age. (Many of the products
currently state "do not use" in children under 2 years of age.)
Additionally, the manufacturers are introducing new child-resistant
packaging and new measuring devices for use with the products.
voluntary actions will not affect the availability of the medicines,
but will result in a transition period where the instructions for using
some OTC cough and cold medicines in children will be different from
others. Some product instructions will state "do not use" in children
under 4 years of age, while others will instruct not to use in children
under 2 years of age.
FDA does not typically request
that OTC products with previous labeling be removed from the shelves
during a voluntary label change such as this one. The agency recommends
following the dosage instructions and warnings on the label that
accompanies the medication if you have or buy a product that does not
have the voluntarily modified labeling.
Recent FDA Actions
has held two public meetings over the past year on the safe use of
nonprescription OTC cough and cold medicines in children. The most
recent meeting on Oct. 2, 2008, focused on labeling of these products.
issued a nationwide Public Health Advisory in January 2008 recommending
that these products not be used in children under the age of 2 because
of the risk of serious and potentially life-threatening side effects.
continues to reach out to other public health agencies, consumer and
patient groups, drug manufacturers, CHPA, and the scientific community.
As it obtains more up-to-date information and scientific data about the
safety and effectiveness of these products in children, FDA can take
the appropriate regulatory steps moving forward.
Tips for Parents and Caregivers
Do not give children medications labeled only for adults.
to your health care professional, such as your doctor or pharmacist, if
you have any questions about using cough or cold medicines in children.
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.
the "active ingredients" section of the "Drug Facts" label of the
medicines that you choose. This section 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 reliever and fever reducer.
very careful if you are giving more than one medicine to a child. Make
sure the medicines do not have the same type of active ingredients. For
example, do not give a child more than one medicine that has a
decongestant. If you use two medicines that have the same or similar
active ingredients, your child could be harmed by getting too much of
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 other health care professional. Overuse or misuse of
these products can lead to serious and potentially life-threatening
side effects, such as rapid heartbeat, drowsiness, breathing problems,
Only use measuring devices that come
with the medicine or those specially made for measuring drugs. Do not
use household spoons to measure medicines for children because
household spoons come in different sizes and are not meant for
Understand that using OTC
cough and cold medicines does not cure the cold or cough. These
medicines only treat your child's symptoms, such as runny nose,
congestion, fever, and aches. They do not shorten the length of time
your child is sick.
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information
Safe Use of Over-the-Counter Drug Products
FDA 101: How to Use the Consumer Complaint System and MedWatch
Your Guide to Reporting Problems to FDA
Improving Medical Products for Children: Q & A with Dianne Murphy, M.D.
Date Posted: October 22, 2008