FDA Urges Caution on Giving Cough and Cold Medicines to Children

Posted on April 29, 2008

FDA is urging parents to be careful when giving cough and cold medications to children, especially those younger than two. Serious and even fatal adverse events can occur if a child is given too much medicine, or it is given too often, or if the child is given more than one medicine that contains the same active ingredient.

Here are some recommendations for parents from the FDA:

• Do not give cough and cold products to children under 2 years old unless specifically directed to do so by a healthcare provider.

• Do not give children medicine that's made for adults. Only use products marked for babies, infants or children, which are sometimes labeled as "pediatric". Caregivers should be sure to read the "Drug Facts" box on the label to understand how to use the product and know the active ingredients and warnings.

• Do not give your child other prescription or non-prescription medicines at the same time as cough and cold medicines without first checking with your child's healthcare provider.

• Do not use kitchen utensils like a teaspoon or tablespoon to measure out liquid medicines. Instead, use the dropper, dosing cup or dosing spoon that comes with the medicine. If a measuring device is not included, buy one at a pharmacy and be sure it has markings that match the dosing recommendations on the drug label or given by your child's healthcare provider.

FDA will hold a public meeting in October to discuss the safety and effectiveness of cough and cold products for children.

Additional Information:

FDA MedWatch Safety Alert. Nonprescription Cough and Cold Medicine Use in Children. August 16, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cough

FDA MedWatch Safety Alert. Cough and Cold Medications in Children Less Than Two Years of Age. January 12, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#coughcold