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Drugs

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Over-the-Counter

Title and Format	Type	Issue Date
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16)	Final	5/1984
General Guidelines for OTC Combination Products	Final	11/1978
Label Comprehension Studies for Nonprescription Drug Products	Draft	4/30/2009
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)	Draft	6/1998
Labeling OTC Human Drug Products -- Questions and Answers	Final	1/2/2009
Labeling OTC Human Drug Products -Submitting Requests for Exemptions and Deferrals	Draft	12/2000
Labeling OTC Human Drug Products; Small Entity Compliance Guide	Final	5/12/2009
Labeling OTC Human Drug Products Updating Labeling in ANDAs Additional examples 1 (3/19/2001) Additional examples 2 (3/26/2001) Additional examples 3 (3/26/2001)	Draft	2/21/2001
Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs Example Drug Facts Labels Acetaminophen 120 mg in a Suppository Dosage Form Acetaminophen 325 mg in a Suppository Dosage Form Acetaminophen 650 mg in a Suppository Dosage Form Cimetidine 200 mg in a Tablet Dosage Form Clemastine Fumerate 1.34 mg in a Tablet Dosage Form Doxylamine Succinate 25 mg Tablet Dosage Form Ibuprofen 200 mg in a Tablet/Capsule Dosage Form Loperamide HCl in a Liquid Dosage Form Loperamide HCl in a Tablet/Caplet Dosage Form Miconazole Nitrate Vaginal Products Minoxidil Topical Solution 2% for Men and Women Minoxidil Topical Solution 5% for Men Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form Pseudoephedrine HCl Extended-Release Tablets 120 mg	Final	10/2002
Labeling OTC Human Drug Products Using a Column Format	Final	12/2000
Labeling OTC Skin Protectant Drug Products	Draft	8/4/2008
Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application	Final	7/13/2009
Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers	Final	8/31/2009
Time and Extent Applications	Draft	2/2004
Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731)	Final	10/1978

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