21 CFR §343.80
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The labeling of an over-the-counter drug product written for health professionals (but not for the general public) shall consist of the following:
REV: October 23, 1998.
- (a)For products containing aspirin identified in §§ 343.12 and 343.13 or permitted combinations identified in § 343.22. (These products must meet United States Pharmacopeia (USP) standards for dissolution or drug release in § 343.90.)
- (1)The labeling contains the following prescribing information under the heading “Comprehensive Prescribing Information” and the subheadings “Description,” “Clinical Pharmacology,” “Clinical Studies,” “Animal Toxicology,” “Indications and Usage,” “Contraindications,” “Warnings,” “Precautions,” “Adverse Reactions,” “Drug Abuse and Dependence,” “Overdosage,” “Dosage and Administration,” and “How Supplied” in the exact language and the exact order provided as follows:
- (2)In addition to, and immediately preceding, the labeling required under paragraph (a)(1) of this section, the professional labeling may contain the following highlights of prescribing information in the exact language and exact format provided, but only when accompanied by the comprehensive prescribing information required in paragraph (a)(1) of this section.
- (b)[Reserved]