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FDA Guidance for Industry - Labeling OTC Human Drug Products — Questions and
Answers (PDF) found on this FDA webpage Labeling OTC Human Drug Products -- Questions and Answers
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OK, now that we can chuckle about the Cheerios label fiasco, here's the scoop on what should go on OTC labels, "FDA Guidance for Industry - Labeling OTC Human Drug Products (PDF)"
In a nutshell, the Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand the new over-the-counter (OTC) labeling requirements set forth in 21 CFR 201.66 and prepare new labeling.
If you're new to this arena, you'll find this a real eye opener. The FDA even regulates things down to the detail of what size font you need to use, and more!
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