Label: 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 28, 2022

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  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

  • Purpose

    Stool softener laxative

  • Uses

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

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • a sudden change in bowel habits that lasts over 14 days

    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 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 (1-800-222-1222) Center right away.

  • Directions

    • take softgels with a full glass (8 oz) of water
    adults and children 12 years and older

    take 1-3 softgels daily or as directed by a doctor.

    This dose may be taken as a single daily dose or in divided doses.
    children 6 to under 12 years of agetake 1 softgel daily or as directed by a doctor
    children under 6 years of ageask a doctor

  • Other information

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

    black iron oxide, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, hypromellose,  polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 7AM-6PM PST

  • Principal Display Panel

    Compare to the active ingredient in Phillips® Stool Softener††

    Stool Softener

    DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE

    Cramp Free

    • Gentle & dependable relief of occasional constipation
    • Stimulant free

    SOFTGELS

    ††This product is not manufactured or distributed by Bayer HealthCare LLC., distributor of Phillips'® Stool Softener.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com

  • Product Label

    Docusate Sodium 100 mg

    WALGREENS Stool Softener Laxative

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8540
    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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    Colorred, whiteScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code P10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8540-301 in 1 BOX12/27/2019
    130 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 finalpart33412/27/2019
    Labeler - Walgreens (008965063)
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