Label: LAXATIVE- sennosides tablet, sugar coated

  • NDC Code(s): 70000-0443-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 19, 2023

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  • Active ingredient (in each tablet)

    Sennosides USP, 15 mg

  • Purpose

    Stimulant laxative

  • Uses

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

    Do not use

    laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

    Ask a doctor before use if you have

    noticed a sudden change in bowel habits that persists over a period of 2 weeks.

    Ask a doctor or pharmacist before use if you are

    taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

    When using this product

    do not use for a period longer than 1 week.

    Stop use and ask a doctor if

    rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may 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

    • swallow tablet(s) with a glass of water
    • swallow tablet(s) whole; do not crush, break, or chew
    adults and children 12
    years and over    		2 tablets once or
    twice daily
    children 6 to under
    12 years    		1 tablet once or
    twice daily
    children under 6 yearsask a doctor

  • Other information

    • each tablet contains: calcium 45 mg, magnesium 5 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate dihydrate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    LEADER™

    NDC 70000-0443-1

    Regular Strength
    Laxative

    Sennosides USP, 15 mg
    Stimulant Laxative

    Gentle, Dependable
    Constipation Relief

    30 TABLETS

    Actual Size

    COMPARE TO
    ex•lax® REGULAR
    STRENGTH
    active ingredient*

    100% Money
    Back Guarantee

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark ex•lax® Regular Strength.

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

    ©2021 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.

    50844   REV0419A34701

    100% Money Back Guarantee
    Return to place of purchase.

    Leader 44-347

    Leader 44-347

  • INGREDIENTS AND APPEARANCE
    LAXATIVE 
    sennosides tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0443
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES15 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorbrown (Tan) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;347
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0443-12 in 1 CARTON03/01/2019
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/01/2019
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70000-0443)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(70000-0443)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(70000-0443)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(70000-0443)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70000-0443)
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