New Labels for Non-prescription Cough and Cold Medications

Most makers of nonprescription cough and cold medicines are voluntarily changing the labels on these products to say "do not use" for children under 4 years of age. New child resistant packaging and measuring devices are also being introduced.

The changes were recently announced by the Consumer Healthcare Products Association (CHPA), which represents most of these manufacturers. FDA supports this action, which reflects a more restrictive use of these drugs in children.

FDA is working with other public health and scientific organizations to obtain, analyze and make available the most up-to-date information about the effects of these medicines on children, and FDA will take additional action as needed. In the meantime, here are some reminders for parents and caregivers:

• First, understand that these medicines do not cure a cold or cough or shorten its duration. They only treat a child's symptom(s) such as a runny nose, congestion, fever and aches.

• Do not give children medications labeled only for adults.

• Choose OTC cough and cold medicines with child-resistant safety caps, where possible. Be sure to close the cap tightly after use, and store the medication out of reach of children.

• Check the "Drug Facts" on the label, which tells how much medicine to give and how often to give it. Misusing or using too much of these products can cause serious and even life threatening side effects such as rapid heartbeat, drowsiness, suppression of the respiratory system and seizures.

• Be careful when giving a child more than one medicine. Using two medicines with the same or similar active ingredients could give a child too much of that drug.

• Only use measuring devices that come with the medicine, or those specially made for measuring drugs.

• Finally, if you have questions or are not sure how to use a product, check with the doctor or pharmacist.

FDA Patient Safety News: Jan/Feb 2009

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=83#7

Category:

Education

Tags:

• Children
• infant
• baby
• cough
• cold
• fever
• congestion
• runny nose
• FDA
• drug
• side effect
• label
• adverse event

[AskCarrieLee]

Not sure I agree with under 4. Perhaps saying not for use under 2, which it now says, "under 2 do not use without the direction of a doctor". For god sakes people, ASK YOUR PHARMACIST!!!