§343.90. Dissolution and drug release testing. — Inbound Citations

Combinations containing aspirin must meet the standards of an acceptable dissolution test, as set forth in § 343.90. The following combinations are permitted: Aspirin identified in §§ 343.12 and 343.13 may be combined with any antacid ingredient identified in § 331.11 of this chapter or any combination of antacids permitted in accordance with § 331.10(a) of this chapter provided that the finished product meets the requirements of § 331.10 of this chapter and is marketed in a form intended for ingestion as a solution.

(a) (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:

REV: October 23, 1998.

(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.