# Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use; Required Alcohol Warning
> **Food and Drug Administration** · Final rule. · Published 1998-10-23 · Effective 1999-04-23 · 63 FR 56789
## Document
- **Document number:** 98-28520
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 56789
- **CFR reference:** 21 CFR 201
- **Publication date:** 1998-10-23
- **Effective date:** 1999-04-23
- **HHS docket:** Docket No. 77N-094W
## Abstract

The Food and Drug Administration (FDA) is amending its regulations to require an alcohol warning for all over-the-counter (OTC) drug products, labeled for adult use, containing internal analgesic/antipyretic active ingredients. The required warning statements advise consumers with a history of heavy alcohol use to consult a physician for advice about the use of OTC internal analgesic/ antipyretic drug products. FDA is issuing this final rule after considering comments on the agency's proposed regulation for OTC internal analgesic, antipyretic, and antirheumatic drug products; a proposed regulation to establish an alcohol warning; recommendations of its Nonprescription Drugs Advisory Committee (NDAC) and Arthritis Drugs Advisory Committee (ADAC); and new data and information that have come to the agency's attention. This final rule is part of the ongoing review of OTC drug products conducted by FDA.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/10/23/98-28520/over-the-counter-drug-products-containing-analgesicantipyretic-active-ingredients-for-internal-use)
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