Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol; Amendment of Final Rule

Resumen

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