Label: LEADER WOMENS LAXATIVE- bisacodyl tablet, coated

  • 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 January 22, 2021

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  • Active ingredient (in each tablet)

    Bisacodyl USP 5 mg

  • Purpose

    Laxative

  • Uses

    ▪
    for relief of occasional constipation and irregularity
  • Warnings

    Ask a doctor before use if you have

    ▪
    abdominal pain
    ▪
    nausea
    ▪
    vomiting
    ▪
    a sudden change in bowel habits that persists over a period of 2 weeks

    When using this product

    ▪
    you may experience stomach discomfort, faintness, and cramps may occur
    ▪
    Swallow tablets whole, do not chew or crush
    ▪
    do not use within 1 hour after taking an antacid or milk
    ▪
    expect results in 6-12 hours

    Stop use and ask a doctor if

    ▪
    you fail to have a bowel movement after use
    ▪
    rectal bleeding occurs
    ▪
    you need to use a laxative for more than one week

    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 Immediately.

  • Directions

    adults and children 12 years of age and over

    take 1 to 3 tablets in a single dose once daily

    children 6 to under 12 years of age

    take 1 tablet in a single dose once daily

    children under 6 years of age

    ask a doctor
  • Other information

    ▪
    do not use if individual blister compartments are broken or open
    ▪
    Store at room temperature
    ▪
    Protect from moisture
    ▪
    Retain carton for complete information
  • Inactive ingredients

    acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #7 calcium lake, hypromellose phthalate, Iron oxide, Iron oxide black, Iron oxide yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin.

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Correctol® Tablets active ingredient

    Women’s Laxative

    Bisacodyl USP 5 mg

    For Gentle, Dependable Overnight Relief

    For Gentle, Overnight Relief from Irregularity

    SATISFACTION GUARANTEED

    30 COATED TABLETS

    Distributed By:

    Cardinal Health

    Dublin, Ohio 43017

    www.myleader.com

    CIN 2712586

    Woman Laxative 30 Coated Tablets

    Women's Laxative Carton

  • INGREDIENTS AND APPEARANCE
    LEADER WOMENS LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-298
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorPINK (polished) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 174
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-298-652 in 1 CARTON08/16/2019
    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 not finalpart33408/16/2019
    Labeler - Cardinal Health (097537435)
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