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Use Caution with Cough and Cold Medicines for Children

Giving children too much cough and cold medicine can be dangerous, according to an FDA public health advisory issued on August 15, 2007. Over-the-counter (OTC) cough and cold products can be harmful if more than the recommended amount is used, if it is given too often, or if more than one product containing the same active ingredient is being used.

FDA's advice for parents includes:

  • Read all of the information in the "Drug Facts" box on the package label and follow directions carefully.
  • Do not use cough and cold products in children under 2 years old unless you receive specific directions to do so by a health care provider.
  • Do not give medicine to a child more often or in greater amounts than is stated on the package. Too much medicine may lead to serious and life-threatening side effects.
  • Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called "pediatric" use).
  • Ask a health care provider if you are unsure about the right product for your child. Cough and cold medicines come in many different strengths.
  • Tell your health care provider about any other medicines (OTC or prescription) that are being given. This is so that your child's health care provider can review and approve their combined use.
  • Use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with the medicine. A kitchen teaspoon is not an appropriate measuring device for giving medicines to children.

Advisory Committee Meeting

Questions have been raised about the safety of these products in children and whether the benefits justify any potential risks, especially in children under 2 years old.

FDA's Nonprescription Drugs Advisory Committee will discuss these issues on October 18 and 19, 1007. In preparation for the meeting, FDA is reviewing safety and effectiveness data for the ingredients of these products.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: August 16, 2007

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