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

  • NDC Code(s): 59726-853-01, 59726-853-10, 59726-853-40
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 30, 2024

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

  • Directions

    • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
    adults and children 12 years and overtake 1-3 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

    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 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

    Softgels

    †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace Regular Strength Stool Softener.

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

    Distributed by: PL Developments

    200 Hicks Street, Westbury, NY 11590

  • Product Label

    Docusate Sodium 100 mg

    WELLNESS BASICS Stool Softener Laxative

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER LAXATIVE 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-853
    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:59726-853-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2020
    2NDC:59726-853-011000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2020
    3NDC:59726-853-40400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/31/2020
    Labeler - P & L Development, LLC (800014821)
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