Label: GENTLE STOOL SOFTENER- 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 November 2, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient (in each liquid-filled capsule)

    Docusate sodium 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • 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 you have

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

    • take with a glass of water
    • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
    adults and children 12 years and overtake 1 to 3 capsules daily
    children 2 to under 12 yearstake 1 capsule daily
    children under 2 yearsask a doctor
  • Other information

    • each capsule contains: sodium 6 mg
      Very Low Sodium
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from excessive humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

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

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Walgreens

    Gentle Stool Softener

    Compare to Dulcolax®
    Stool Softener
    active ingredient††

    NDC 0363-0655-56

    • Gentle & easy relief of occasional constipation

    DOCUSATE SODIUM 100 mg /
    STOOL SOFTENER LAXATIVE

    25
    LIQUID GELS

    ACTUAL SIZE

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

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com ©2018 Walgreen Co.
    PRODUCT OF CHINA, PACKAGED AND
    QUALITY ASSURED IN THE U.S.A.

    Walgreens Pharmacist Recommended
    Walgreens Pharmacist Survey
    ††This product is not manufactured or
    distributed by Sanofi-Aventis Deutschland
    GMBH, owner of the registered trademark
    Dulcolax® Stool Softener.

    50844     REV0218A65556

    Walgreens 44-655

    Walgreens 44-655

  • INGREDIENTS AND APPEARANCE
    GENTLE STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0655
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colororange (Clear) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 655
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0655-561 in 1 CARTON03/01/201502/24/2023
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/201502/24/2023
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0363-0655)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0363-0655)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0363-0655)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-0655)