Label: STOOL SOFTENER- docusate sodium capsule

  • NDC Code(s): 49035-207-50
  • 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 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces bowel movement in 12 to 72 hours
  • Warnings

    Do not use

    if you are presently taking mineral oil, unless told to do so by a doctor.

    Ask a doctor before use if

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


    Ask a doctor or pharmacist before use if you are

    presently taking mineral oil

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding,

    ask a health care 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

    • take with a glass of water
    adults and children 12 over and overtake 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
    children 2 to under 12 years of agetake 1 softgel daily
    children under 2 years ask a doctor
  • Other information

    • each softgel contains: sodium 6 mg
    • store 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)


  • Inactive ingredients

    edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

    *contains one or more of these ingredients

  • Questions or comments?

     Call 1-888-287-1915

  • Principal Display Panel

    Compare to the active ingredient in DulcoEase® Stool Softener†

    Stool Softener

    Docusate sodium 100 mg

    Stool Softener Laxative

    • Comfortable Relief of Painful, Hard, Dry Stools
    • Stimulant-Free
    • Constipation Relief

    SOFTGELS

    †This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceutical, Inc., distributor of DulcoEase®.

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

    DISTRIBUTED BY:

    Walmart Inc.,

    Bentonville, AR 72716

  • Product Label

    Docusate Sodium 100 mg

    EQUATE Stool Softener

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-207
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITAN (UNII: 6O92ICV9RU)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code P51;SCU1;D2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-207-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/201901/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/30/201901/31/2025
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)
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