Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

  • NDC Code(s): 70677-1096-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 31, 2024

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  • Active ingredient (in each softgel)

     Docusate sodium 250 mg

  • Purpose

     Stool softener laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • 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 13 mg
    • store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
  • Inactive Ingredients

    anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink

  • Questions or comments?

    Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

  • Principal Display Panel

    EXTRA STRENGTH

    Stool Softener

    Docusate Sodium 250 mg

    STOOL SOFTENER LAXATIVE

    • Stimulant-free
    • Relief of Occasional Constipation

    SOFTGELS

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

    Distributed by:  McKesson Corp.,

    via SSSl Memphis, TN 38141

    www.fosterandthrive.com

  • Product Label

    Docusate Sodium 250 mg

    FOSTER & THRIVE Extra Strength Stool Softener

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1096
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MANNITOL (UNII: 3OWL53L36A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    Colororange (red) Scoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1096-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/01/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
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