Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol; Amendment of Final Rule
other · US Department of Health and Human Services · Rule · Published 1996-11-18 · 61 FR 58629
Document
Document number
96-29387
Federal Register citation
61 FR 58629
CFR reference
21 CFR 328
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-11-18
HHS docket
Docket No. 95N-0341
Abstract
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.