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FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.

MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2018.

Addressing the opioid epidemic has necessitated new approaches to prevent opioid misuse. This announcement describes new FDA requirements regarding labeling changes for prescription cough and cold medicines containing codeine or hydrocodone in pediatric patients.