Label: STOOL SOFTENER EXTRA STRENGTH- docusate sodium capsule, liquid filled

  • NDC Code(s): 49035-848-14
  • Packager: EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART 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 October 25, 2022

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  • Active ingredient (in each softgel)

    Docusate sodium 250 mg

  • Purpose

     Stool softener laxative

  • Uses

    • for the prevention of dry, hard stools
    • 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 at 20º-25ºC(68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • Inactive Ingredients

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

    *may contain this ingredient

  • Questions or comments?

    Call 1-888-287-1915

  • Principal Display Panel

    EXTRA STRENGTH

    Stool Softener

    Docusate Sodium  250 mg

    • Stimulant-free
    • Relief of constipation

    SOFTGELS

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

    Distributed by:

    Wal-Mart Stores, Inc.,

    Bentonville AR 72716

  • Product Label

    Docusate sodium 250 mg

    Equate Stool Softener Laxative

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER  EXTRA STRENGTH
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-848
    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)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P20;SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-848-14140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/201902/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/01/201902/01/2025
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)
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