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Health Byte |
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Public Health
Advisory
Date created: January 17, 2008 |
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Nonprescription Cough
and Cold Medicine Use in Children
FDA Recommends that
Over-the-Counter (OTC) Cough and Cold Products not
be used for Infants and Children under 2 Years of
Age
FDA has completed its review
of information about the safety of over-the-counter
(OTC) cough and cold medicines in infants and
children under 2 years of age. FDA is recommending
that these drugs not be used to treat infants and
children under 2 years of age because serious and
potentially life-threatening side effects can occur.
FDA’s recommendation is
based on both the review of the information we
received about serious side effects in children and
the discussion and recommendations made at the
October 18–19, 2007,
public advisory committee
meeting at which this issue was
discussed. FDA strongly supports the actions taken
by many pharmaceutical manufacturers to voluntarily
withdraw cough and cold medicines that were being
sold for use in this age group.
FDA has not completed its
review of information about the safety of OTC cough
and cold medicines in children 2 through 11 years of
age. We are aware of reports of serious side effects
from cough and cold medicines in children 2 years of
age and older. FDA is committed to completing its
comprehensive and thorough review of the safety of
OTC cough and cold medicines in children 2 years of
age and older as quickly as possible and expects to
communicate our recommendations to the public in the
near future.
Pending completion of FDA’s
ongoing review, if parents and caregivers use OTC
cough and cold medicines in children 2 years of age
and older, FDA recommends:
Checking the “active
ingredients” section of the DRUG FACTS label.
This will help
you understand what “active ingredients” are in
the medicine and what symptoms each active
ingredient is 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/fever reducer).
Being very careful if
you are giving more than one OTC cough and cold
medicine to a child.
Many OTC cough and cold medicines have more
than one “active ingredient.” If you use two
medicines that have the same or similar “active
ingredients” a child could get too much of an
ingredient which may hurt your child. For
example, do not give a child more than one
medicine that has an antihistamine.
Carefully following
the directions in the DRUG FACTS part of the
label. These
directions tell you how much medicine to give
and how often you can give it.
Only using the
measuring spoons or cups that come with the
medicine or those made specially for measuring
drugs. Do not
use common household spoons to measure
medicines for children since household spoons
come in different sizes and are not meant for
measuring medicines.
Choosing OTC cough and
cold medicines with childproof safety caps,
when available, and store the medicines out of
the reach of children.
Understanding that
using OTC cough and cold medicines are intended
only to treat your child’s symptom(s).
OTC cough and cold medicines do not treat the
cause of the symptoms or shorten the length of
time your child is sick. They only relieve
symptoms and make your child feel more
comfortable.
Not using these
products to sedate your child or make children
sleepy.
Calling a physician,
pharmacist, or other healthcare professional if
you have any questions about using cough or
cold medicines in children 2 years of age and
older.
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