Label: STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium 50 mg and sennosides 8.6 mg tablet, film coated

  • NDC Code(s): 70000-0526-1
  • Packager: CARDINAL HEALTH, 110 DBA LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 29, 2021

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  • Active Ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Stimulant laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 6 to 12 hours
  • Warnings

    Do not use

    • laxative products for longer than 1 week unless told to do so by a doctor
    • 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 the use of a laxative.

    These could be sings of a serious condition.

    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 (1-800-222-1222).

  • Directions

    • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses

    adults and children 12 years and over

    take 2-4 tablets daily

    children 6 to under 12 years of age

    take 1-2 tablets daily

    children 2 to under 6 years of age

    take upto 1 tablet daily

    children under 2 

    ask a doctor

  • Other information

    • each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
    • store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF)
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

  • Questions?

    (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    LEADER TM

    NDC 70000-0526-1

    Stool Softener +

    Stimulant Laxative

    Docusate Sodium, 50 mg

    Sennosides, 8.6 mg

    COMPARE TO

    COLACE® 2-IN-1

    active ingredients*

    100% Money

    Back Guarantee

    100 TABLETS

    Leader Stool Softener + Stimulant Laxative Tablet 100 ct. Product Label

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER PLUS STIMULANT LAXATIVE 
    docusate sodium 50 mg and sennosides 8.6 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0526
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUND (ROUND TABLET) Size10mm
    FlavorImprint Code PH32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0526-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/23/2019
    Labeler - CARDINAL HEALTH, 110 DBA LEADER (063997360)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(70000-0526) , analysis(70000-0526) , pack(70000-0526) , label(70000-0526)
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