FDA Supports Cough Remedy Voluntary Labeling Change

Move tightens earlier restriction on use of cough and cold remedies in children under 2 years
By Jane Parry
HealthDay Reporter

FRIDAY, Oct. 10 (HealthDay News) -- The U.S. Food and Drug Administration has issued a statement in support of the members of the Consumer Healthcare Products Association who will voluntarily change the labeling of non-prescription over-the-counter cough and cold remedies to state that they should not be given to children under the age of 4 years.

As the labeling change is voluntary, products with the earlier label stating the medicine is not suitable for children under the age of 2 years will not be subject to a recall, and for a period there will be over-the-counter cough and cold medications with two different instructions for use in children on the market at the same time, the FDA statement notes. The FDA's advice to parents is to follow the directions on the packaging.

The FDA has been working in a number of ways to address safety issues associated with safe use of non-prescription over-the-counter cough and cold medicines in children, and will continue to collaborate with the U.S. Centers for Disease Control and Prevention to monitor the use of these products, the statement explains.

"The Agency will also continue to reach out to the scientific community to obtain more up-to-date information and scientific data about the effects of these products in children so that it can take the appropriate regulatory steps moving forward," the statement says.

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