Label: STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled

  • NDC Code(s): 0363-0016-06, 0363-0016-20, 0363-0016-40
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2023

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  • Active ingredient (in each softgel)

    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 only by mouth. Doses may be taken as a single daily dose or in divided doses.
    adults and children12 years and over take 1-3 softgels daily 
    children 2 to under 12 years of age  take 1 softgel daily
    children under 2 years ask a doctor 

  • Other information

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

    D&C red #33*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

    *contains one or more of these ingredients

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Colace® Regular Strength Stool Softener††

    Stool Softener

    DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE

    REGULAR STRENGTH SOFTGELS

    •  Effective relief of constipation
    • Gentle & dependable
    • Stimulant free

    SOFTGELS

    ††This product is not manufactured or distributed by Purdue Products L.P. , distributor of Colace® Regular Strength 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

  • PACKAGE LABEL

    Docusate Sodium 100 mg

    WALGREENS Stool Softener

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER LAXATIVE 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0016
    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)  
    Product Characteristics
    Colorred, whiteScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code P10;SCU2;D1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0016-061 in 1 BOX08/31/201712/31/2025
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-0016-201 in 1 BOX08/31/201712/31/2025
    2200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0363-0016-401 in 1 BOX08/31/201712/31/2025
    3400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00708/31/201712/31/2025
    Labeler - Walgreens (008965063)
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