OTC lozenges
Executive Summary
FDA sanctifies term "lozenge" as the only acceptable name for solid oral dosage forms to be dissolved in the mouth. Statement is part of amendment to OTC antitussive products in the Oct. 2 Federal Register. The monograph had previously used the terms "lozenge" and "compressed tablet" interchangeably. Agency is also revising its definition of lozenge, in accordance with a new U.S. Pharmacopeial definition, to claify that oral antitussive drugs with intended systemic effects may be formulated as lozenges.