New OTC labeling guidance
This article was originally published in The Tan Sheet
Executive SummaryFDA clarifies in the Federal Register Jan. 5 how OTC drug monograph labeling should appear in the OTC Drug Facts labeling format. The guidance answers frequently asked questions, such as what labeling information must appear on all OTC drug products; how to convert drug warnings into bulleted text; where to place tamper-evident statements on packaging and when pictograms are appropriate, among other questions
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