Label: DOCUSATE SODIUM 250MG- docusate sodium capsule

  • 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 May 18, 2016

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    Docusate Sodium 250 mg

  • PURPOSE

    IMPORTANT

    This is a bulk shipment, intended for further processing only. It is not to be used in its present condition and it should be repackaged immediately and labeled strictly in conformance with the Federal Food, Drug and Cosmetic Act and other pertinent government regulations. 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Olds SoftGels Inc

  • DOSAGE & ADMINISTRATION

    All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

  • WARNINGS

    All complaints or claims for allowances of any kind must be made within 10 days after receipt of goods.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Red No. 40

    Granular FD and C

    Yellow No.6

    Granular

    Gelatin

    Glycerin USP 99 Percent

    Polyethylene

    Glycol 400 USP PEG 400

    Propylene glycol

    Purified water

    Sorbitol special GC

  • PRINCIPAL DISPLAY PANEL

    LABELPACKAGE LABEL

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 250MG 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69160-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorred (40) , yellow (6) Scoreno score
    ShapeOVALSize23mm
    FlavorImprint Code GC425
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69160-003-017000 in 1 BOX; Type 0: Not a Combination Product05/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/18/2016
    Labeler - Olds Softgels Inc. (202822235)
    Establishment
    NameAddressID/FEIBusiness Operations
    Olds Softgels Inc.202822235manufacture(69160-003)