Label: STOOL SOFTENER- docusate sodium capsule

  • NDC Code(s): 80136-951-80
  • Packager: NORTHEAST PHARMA (Heartland Pharma)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 11, 2024

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  • Active Ingredient (in each softgel)

    Docusate Sodium 100 mg

    Purpose

    Stool softener laxative

  • Purpose

    Stool Softener Laxative

  • Uses

    • relieves occasional constipation and irregularity
    • generally produces a bowel movement in 12 to 72 hours.
  • Warnings

    Do not use

    if you are presently taking mineral oil, unless directed by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • a sudden change in bowel habits that lasts more than 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding or no bowel movement after using 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 care 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 5 mg
    • store at 25oC (77o); excursions 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

  • Questions or Comments ?

    Call 1-800-383-0648

  • Principal Display Panel

    Compare to active ingredient in COLACE®  REGULAR STRENGTH†

    STOOL  SOFTENER

    Docusate Sodium 100 mg

    Stool Softener Laxative

    • Gentle
    • dependable
    • Stimulant-Free

    Softgels

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

    Distributed by NORTHEAST PHARMA

    South Burlington, VT 05403

    www.heartlandpharma.com

  • Product Label

    Docusate Sodium 100 mg

    HEARTLAND PHARMA Stool Softener

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-951
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code P51
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80136-951-80100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/202106/28/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00706/28/202106/28/2025
    Labeler - NORTHEAST PHARMA (Heartland Pharma) (081232935)
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