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

  • NDC Code(s): 36800-568-10
  • Packager: TOP CARE (Topco Associates LLC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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  • Active ingredient (in each softgel)

    Docusate sodium 250 mg

  • Purpose

     Stool softener laxative

  • Uses

    • for relief of occasional constipation
    • this product generally produces a bowel movement within 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
    • noticed a sudden change in bowel habits that last 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

    • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
    • children under 12 years of age: ask a doctor
  • Other information

    • each softgel contains: sodium 15 mg
    • store between  20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
  • Inactive Ingredients

    edible white ink, FD&C red #40, FD&C yellow #6,elatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol


  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    EXTRA STRENGTH

    Stool Softener

    DOCUSATE SODIUM, 250 mg

    STOOL SOFTENER LAXATIVE

    • Easy to swallow
    • Relieves constipation

    SOFTGELS

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

    DISTRIBTRED BY TOPCO ASSOCIATES LLC

    ELT GROVE VILLAGE, IL 60007

    www.topcarebrand.com

    topcare®topco.com

  • Product Label

    Docusate Sodium 250 mg

    TOPCARE HEALTH Extra Strength Stool Softener

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER LAXATIVE  EXTRA STRENGTH
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-568
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 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)  
    MANNITOL (UNII: 3OWL53L36A)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-568-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/201908/29/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00711/29/201908/29/2026
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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