Label: DOCUSATE SODIUM capsule, liquid filled
- NDC Code(s): 48433-101-01
- Packager: Safecor Health, LLC
- This is a repackaged label.
- Source NDC Code(s): 54629-601
- 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 January 26, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Keep Out of Reach of Children.
- Uses
- Warnings
- Ask a doctor before use
- Stop use and ask a doctor
- If you are pregnant or breast-feeding,
- Directions
- Other Information
- Inactive ingredients
- Questions
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48433-101(NDC:54629-601) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 250 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED Score no score Shape OVAL Size 20mm Flavor Imprint Code NV12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48433-101-01 100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 05/01/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/01/2000 Labeler - Safecor Health, LLC (828269675) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 078805287 REPACK(48433-101)