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With More OTC Drugs On Radar, US FDA Reminds Industry Of Statement Of Identity Requirements

Consumer Self-Care Also Noted In Sodium, Potassium, Phosphorous Labeling Recommendations

Executive Summary

Draft guidances published on statements of OTC drug identity and strength and on labeling of sodium, potassium and phosphorous levels. Recommendations come as agency and drug industry anticipate more OTC remedies becoming available through proposed ACNU rule and streamlined monograph program.

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