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www.fdanews.com/articles/113481-fda-answers-otc-drug-labeling-guidance-questions

FDA Answers OTC Drug Labeling Guidance Questions

January 6, 2009
OTC drug manufacturers, packers and distributors got new guidance from the FDA with examples that show standardized format and content that meet human-drug labeling requirements. The drug-facts labeling for OTC products is intended to make it easier for consumers to read and understand the labeling and use the drugs safely and effectively.
Drug Industry Daily