Label: STOOL SOFTENER AND STIMULANT LAXATIVE- docusate sodium and sennosides capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • PURPOSE

    Purpose
    Stool softener
    Stimulant Laxative

  • ACTIVE INGREDIENT

    Active ingredients
    (in each softgel) 
    Docusate sodium 50 mg
    Sennosides 8.6 mg

  • SPL UNCLASSIFIED SECTION

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6-12 hours
  • WARNINGS

    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 may indicate 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 (1800-222-1222) 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 of age or over take 2-4 softgels daily
     children 6 to under 12 years of age       take 1-2 softgels daily
     children 2 to under 6 years of age    take upto 1 softgel daily
     children under 2 ask a doctor

  • Other information

    • each softgel contains: calcium 2 mg and sodium 3 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • Keep tightly closed
  • Inactive ingredients

    Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide

  • Questions or Comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Purdue
    Products L.P., owner of the registered trademark Colace® 2-IN-1.


    © 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
    the Cardinal Health LOGO, LEADER, and the Leader LOGO are
    trademarks or registered trademarks of Cardinal Health. All other
    marks are the property of their respective owners.

    DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
    www.myleader.com 1-800-200-6313
    Made in India

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

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

    KEEP OUTER CARTON FOR COMPLETE
    WARNINGS AND PRODUCT INFORMATION

  • PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Carton

    Leader™

    NDC 70000-0442-1

    Stool
    Softener +
    Stimulant
    Laxative

    Docusate Sodium, 50 mg
    Sennosides, 8.6 mg

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

    100% Money
    Back Guarantee

    60 SOFTGELS 

    Actual Size

    image description

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER AND STIMULANT LAXATIVE 
    docusate sodium and sennosides capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0442
    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
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Product Characteristics
    Colorred (OPAQUE) Scoreno score
    ShapeCAPSULE (SOFTGEL) Size12mm
    FlavorImprint Code 584
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0442-11 in 1 CARTON01/30/2019
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/30/2019
    Labeler - Cardinal Health (063997360)
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