Label: DOCUSATE SODIUM tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69160-002-01, 69160-002-03 - 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 September 14, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
docusate sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69160-002 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 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 white Score no score Shape OVAL Size 18mm Flavor Imprint Code 401 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69160-002-01 18000 in 1 BOX; Type 0: Not a Combination Product 05/19/2015 2 NDC:69160-002-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/19/2015 Labeler - Olds Softgels Inc. (202822235) Establishment Name Address ID/FEI Business Operations Olds Softgels Inc. 202822235 manufacture(69160-002) , label(69160-002) , pack(69160-002)
