Label: LEADER SENNA LAXATIVE- sennosides tablet

  • 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 March 5, 2012

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  • Active Ingredients (in each tablet)

    Sennosides 8.6mg

    Purpose

    Stool softener
    Stimulant Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement within 6 to 12hours.
  • Warnings - Do not use

    • laxative products for longer than 1 week 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 movements that continues over a period of 2 weeks.

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use. These could be signs of a serious condition

    If pregnant or breastfeeding

    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 preferably at bedtime or as directed by a doctor

                                                                                         age; starting dosage; maximum dosage

    • adults and children 12 years of age: 2 tablets once a day; 4 tablets twice a day.
    • children 6 to under 12 years of age: 1 tablet once a day; 2 tablets twice a day
    • children 2 to under 6 years of age:   1/2 tablet once a day; 1 tablet twice a day
    • children under 2: ask a doctor; ask a doctor
  • Other information


    • each tablet contains: calcium 25mg/tablet
    • store at 25C (77F); excursions permitted between 15 - 30 degrees C (59-86 degrees F)
    • do not use if imprinted safety seal under cap is broken or missing.
    • *This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Senokot.
  • Inactive Ingredients

    colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypromellose, maltodextrin, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG), stearic acid, talk, triacetin. *May also contain.

  • Questions or comments?

    call toll free:1-800-200-6313

  • PRINCIPAL DISPLAY PANEL

    Comapre to Senokot active ingredient *

    Leader

    Senna Laxative
    Sennosides, 8.6mg

    Natural Vegetable Laxative for Relief of Constipation
    100 Tablets

    Distributed by Cardinal Health
    Dublin, Ohio 43017
    CIN 1382639

    www.myleader.com
    1-800-200-6313

    All Leader Brand Products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

  • Product Labeling

    Stool Softener

  • INGREDIENTS AND APPEARANCE
    LEADER SENNA LAXATIVE 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-241
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorbrown (BROWN) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code S3;TLC080;S8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-241-78100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2012
    Labeler - Cardinal Health (097537435)
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