FDA Exempts ipecac Syrup from Alcohol Concentration Limits for Children Under 6

Summary

The FDA is issuing a final rule amending the regulations for over-the-counter (OTC) drug products intended for oral ingestion that contain alcohol, exempting ipecac syrup from the maximum concentration limits of 0.5 percent alcohol or less when used by children under 6 years of age, as part of the ongoing review of OTC drug products conducted by the agency.