Label: DOCUSATE SODIUM- docusate sodium capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 66424-030-01, 66424-030-10 - Packager: SDA Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 16, 2011
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- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66424-030 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium 100 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (Two toned- white and clear red) Score no score Shape OVAL Size 5mm Flavor Imprint Code 51A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66424-030-01 100 in 1 BOTTLE 2 NDC:66424-030-10 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/15/2010 Labeler - SDA Laboratories, Inc. (948067889) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc 557054835 repack