Fed Regist. 2011 Jul 26;76(143):44475-89.
The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an "Asthma alert'') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products.
美国食品药品监督管理局（FDA）正在修订非处方（OTC）支气管扩张剂药品的最终专论（FM），以添加更多警示（如“哮喘警示”），并修订含有麻黄碱、盐酸麻黄碱、硫酸麻黄碱、肾上腺素、重酒石酸肾上腺素、盐酸消旋麻黄碱和盐酸消旋肾上腺素成分产品标签中的适应症、警示和用法说明。FDA在考虑了针对该机构对这些产品标签修订提议所提交的数据和信息后发布了本最终规则。本最终规则是FDA对OTC药品持续审查的一部分。
