Label: DOCUSATE SODIUM 250MG- docusate sodium capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 69160-003-01 - Packager: Olds Softgels 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 April 2, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM 250MG
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69160-003 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color red (40) , yellow (6) Score no score Shape OVAL Size 23mm Flavor Imprint Code GC425 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69160-003-01 7000 in 1 BOX; Type 0: Not a Combination Product 05/18/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/18/2016 Labeler - Olds Softgels Inc. (202822235) Establishment Name Address ID/FEI Business Operations Olds Softgels Inc. 202822235 manufacture(69160-003)