Makers Say Cough Meds Not for Kids

(October 10, 2008) - The companies that make over-the-counter children's cough medicine say children under four should not use the products. The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, says its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products. (Read about "Medicine Safety")

The action follows by a few days a public meeting held by the Food and Drug Administration (FDA) on the issue.

FDA says supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children.

FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children.

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. The companies are not pulling the current medications off the shelves so you may still find, for months, the old labeling instructions.