Label: GENTLE LAXATIVE- bisacodyl 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 January 23, 2021

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  • Active ingredient(s)

    Bisacodyl 5 mg

  • Purpose

    Stimulant Laxative

  • Use(s)

    ▪
    for temporary relief of occasional constipation and irregularity
    ▪
    this product generally produces bowel movement in 6 to 12 hours
  • Warnings

    Do not use

    if you cannot swallow without chewing

    Ask a doctor before use if you have

    ▪
    stomach pain, nausea or vomiting
    ▪
    a sudden change in bowel habits that lasts more than 2 weeks

    When using this product

    ▪
    do not chew or crush tablet(s)
    ▪
    it may cause stomach discomfort, faintness or cramps
    ▪
    do not use within 1 hour after taking an antacid or milk

    Stop use and ask a doctor if

    ▪
    you have rectal bleeding or no bowel movement after using this product.  These could be signs of a serious condition.
    ▪
    you need to use a laxative for more than 1 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 right away.

  • Directions

    take with a glass of water

    adults and children 12 years and over

    take 1 to 3 tablets in a single daily dose

     children 6 to under 12 years of age

    take 1 tablet in a single daily dose

     children under 6 years of age

    ask a doctor
  • Other information

    ▪
    each tablet contains: sodium less than 0.5mg
    ▪
    store at 20°-25°C (68°-77°F)
    ▪
    protect from excessive humidity
    ▪
    TAMPER EVIDENT: Blister packaged for your protection. Do not use if individual seals are broken
  • Inactive ingredients

    acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

  • Questions

    Call 1-800-200-6313, weekdays, 9am-4pm EST

  • Principal Display Panel

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    TABLETS

    Leader Gentle Laxative

    Overnight Relief of Constipation and Irregularity

    *Compare to the active ingredient of Dulcolax®

    LAXATIVE

    Bisacodyl USP, 5 mg

    25 Coated Tablets

    CIN 2281715

    Distributed By:

    Cardinal Health

    Dublin Ohio 43017

    www.myleader.com

    Leader Gentle Laxative

    Leader Gentle Laxative

  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE 
    bisacodyl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-128
    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)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code TCL;003
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-128-631 in 1 CARTON10/14/2011
    125 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 finalpart33410/14/2011
    Labeler - Cardinal Health (097537435)
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