Label: DOCUSATE SODIUM capsule, liquid filled
- NDC Code(s): 54629-601-01, 54629-601-99
- Packager: National Vitamin Company
- 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 April 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each softgel)
- Purpose
- Uses
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WARNINGS Do not use:
- •
- If you are currently taking mineral oil, unless directed by a doctor.
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- When abdominal pain, nausea, or vomiting are present.
- •
- For longer than one week unless directed by a doctor.
Ask a doctor before use
if you notice a sudden change in bowel habits that persists over a period of two weeks.
- 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: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, UNSPECIFIED (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:54629-601-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2000 2 NDC:54629-601-99 1000 in 1 BOTTLE; 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 - National Vitamin Company (102098324) Establishment Name Address ID/FEI Business Operations National Vitamin Company 102098324 MANUFACTURE(54629-601)