Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph for OTC Antitussive Drug Products

Resumo

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would amend the final monograph for over-the- counter (OTC) antitussive drug products (drug products that relieve cough) to revise the labeling warnings and directions for topical/ inhalant products containing the active ingredients camphor and/or menthol. New information indicates that use of these drug products near an open flame, in hot water, or in a microwave oven can cause the products to catch on fire and cause serious burns to the user. Therefore, the agency is proposing warnings and directions for safer use of these drug products by informing consumers not to expose the products to flame, hot water, or a microwave oven. This proposal is part of the ongoing review of OTC drug products conducted by FDA.