Ephedrine, atropine barred from OTC menstrual, internal analgesic combos in FDA final rule.
This article was originally published in The Tan Sheet
Executive Summary
EPHEDRINE, ATROPINE BARRED FROM OTC MENSTRUAL, INTERNAL ANALGESIC combination products in an FDA final rule scheduled for publication in the Aug. 24 Federal Register. In the rule, the agency states it is "not aware of any information that supports the use of ephedrine or atropine as active ingredients in OTC orally administered menstrual or internal analgesic, antipyretic and antirheumatic drug products. Accordingly, these active ingredients will not be included in the relevant final monographs."