Label: LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE SOFTGEL- docusate sodium, sennosides capsule, liquid filled

  • NDC Code(s): 70000-0684-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 16, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredients (in each softgel)

    Docusate sodium 50 mg
    Sennosides 8.6 mg

  • Purpose

    Stool softener
    Stimulant laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces 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 use of a laxative. These could be signs 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.

  • 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 softgels daily
     children 6 to under 12 years and over take 1-2 softgels daily
     children under 6 years of age ask a doctor

  • Other information

    • each softgel contains: sodium 4 mg
    • store at room temperature between 20°-25°C (68°-77°F)

  • Inactive ingredients

    colloidal silicon dioxide, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, yellow bees wax

  • Questions or comments?

    Call 1-800-200-6313

  • SPL UNCLASSIFIED SECTION

    COMPARE TO COLACE® 2-IN-1 active ingredients*

    All LEADER™ Brand Products Have A 100% Money Back Guarantee
    Return to place of purchase if not satisfied.

    CardinalHealth™

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com
    1-800-200-6313
    Essential to Care™ Since 1979

    Product of India

    ©2024 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

    READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

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

    *This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark COLACE® 2-IN-1.

  • Packaging

    LEADER-0684

  • INGREDIENTS AND APPEARANCE
    LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE SOFTGEL 
    docusate sodium, sennosides capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0684
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 903
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0684-11 in 1 CARTON07/16/2024
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00707/16/2024
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!