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OTC Medications
June 10, 2013
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Following warnings from the U.S. Food and Drug Administration (FDA) and other federal agencies about the safety of over-the-counter (OTC) cough and cold products for children, leading drug companies voluntarily withdrew 14 infant oral medicines in October. Questions have been raised about the safety of these products and whether the benefi ts justify the potential risks they pose, especially in children younger than 2 years of age. The move does not
apply to medicines intended for children older than 2.

An OTC cough and cold medicine can be harmful if a child is given more than the recommended amount, given the medicine too often, or given more than one cough and cold medicine containing the same active ingredient. To avoid giving a child too much medicine, parents should carefully follow the directions and read the “Drug Facts” box on the package label.

According to the American Academy of Pediatrics, several studies indicate that these products are not eff ective in children younger than 6 and can have potentially serious side effects, even when given as directed. Further, dosage guidelines for cold and cold mixtures are based on adult data and thus may be inaccurate for children.

The following are a few things parents should know about using cough and cold products. (For a complete list, visit

- Do not give cough and cold products to children younger than 2 years old unless your healthcare provider specifically directs you to.
- Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes labelled “for pediatric use”).
- If your child is taking other OTC or prescription medicines, make sure your healthcare provider reviews and approves their combined use.