Label: DOCUSATE SODIUM capsule, liquid filled

  • 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 February 22, 2022

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  • Active ingredient (in each softgel)

     Docusate sodium 250 mg

  • Purpose

     Stool softener laxative

  • Uses

    • for relief of occasional constipation
    • this product generally produces a bowel movement within 12 to 72 hours
  • Warnings

    Do not use

    if you are presently taking mineral oil, unless directed by a doctor.

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that last over 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
    • you need to use a laxative for more than 1 week

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
    • children under 12 years of age: ask a doctor
  • Other information

    • each softgel contains: sodium 15 mg
    • store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
  • Inactive Ingredients

    edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan sorbitol


  • Questions or comments?

    Call 1-800-616-2471

  • Principal Display Panel

    Extra Strength

    Docusate Sodium

    250 mg

    Stool Softener

    Laxative

    Softgels

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    Distributed by:

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

  • Product Label

    pdp

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2643(NDC:0904-6999)
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    MANNITOL (UNII: 3OWL53L36A)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-2643-660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/30/2019
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300repack(68071-2643)
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