FDA Statement Following CHPA's Announcement on Nonprescription Over-
the-Counter Cough and Cold Medicines in Children
The U.S. Food and Drug Administration 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. The 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. Read
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