Business · 13/03/1995Updated: 10/18/2026 · 1 min read

FDA Sets Maximum Alcohol Concentration Limits for Over-the-Counter Oral Medications

The US Food and Drug Administration (FDA) has issued a final rule establishing maximum limits for alcohol content in over-the-counter (OTC) oral medications, with varying limits for children and adults, and requiring prominent labeling of alcohol content on product packaging.