Fed Regist. 2001 Sep 27;66(188):49276-8.
The Food and Drug Administration (FDA) is issuing a final rule establishing that cough-cold combination drug products containing any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient are not generally recognized as safe and effective and are misbranded for over-the-counter (OTC) use. FDA is issuing this final rule after receiving no public comments on the agency's proposed nonmonograph status of these specific combination drug products, which was issued in the form of a tentative final monograph for OTC cough-cold combination drug products. This final rule is part of the ongoing review of OTC drug products conducted by FDA.
美国食品药品监督管理局（FDA）正在发布一项最终规定，确定含有任何口服支气管扩张剂活性成分与任何止痛剂或止痛-退烧药、抗胆碱能药、抗组胺药、口服镇咳药或兴奋剂活性成分的感冒止咳复方药品通常不被认为是安全有效的，并且作为非处方药（OTC）使用时属于标签错误。FDA在收到针对该机构关于这些特定复方药品的非专论状态提案（该提案以OTC感冒止咳复方药品暂行最终专论的形式发布）的公众意见后，发布了这项最终规定。这项最终规定是FDA对OTC药品进行持续审查的一部分。
