WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [AMERISOURCE BERGEN]

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WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [AMERISOURCE BERGEN]
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NDC 46122-429-63
Set ID 307757cc-22d5-4401-9e71-e8d2202a538c
Category HUMAN OTC DRUG LABEL
Packager Amerisource Bergen
Generic Name
Product Class
Product Number
Application Number PART334
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  • Active ingredient (in each tablet)

    Bisacodyl USP, 5 mg

  • Purpose

    Stimulant laxative

  • Uses

    • 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)
    • do not use within 1 hour after taking an antacid or milk
    • you may have stomach discomfort, faintness and cramps

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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 (1-800-222-1222) right away.

  • Directions

    • take with a glass of water
    adults and children 12 years and overtake 1 to 3 tablets in a single daily dose
    children 6 to under 12 yearstake 1 tablet in a single daily dose
    children under 6 yearsask a doctor
  • Other information

    • 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)
    • avoid excessive humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    GOOD
    NEIGHBOR
    PHARMACY®

    Compare to Dulcolax® Pink® active ingredient*

    NDC 46122-429-63

    Women's Gentle Laxative
    bisacodyl     USP 5 mg
    (stimulant laxative)

    Overnight Relief of Constipation

    • formulated for sensitive stomachs
    • enteric coated

    25 Tablets | 5 mg Each

    Actual Size

    *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax® Pink®.

    50844   ORG021760756

    GOOD NEIGHBOR PHARMACY BRAND PRODUCTS
    SATISFACTION GUARANTEED

    Distributed By
    AmerisourceBergen
    1300 Morris Drive
    Chesterbrook, PA 19087
    Questions or Concerns?
    www.mygnp.com

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

    Good Neighbor Pharmacy 44-607

    Good Neighbor Pharmacy 44-607

     

  • INGREDIENTS AND APPEARANCE
    WOMENS GENTLE LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-429
    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)  
    AMMONIA (UNII: 5138Q19F1X)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-429-631 in 1 CARTON04/01/2013
    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 FINALpart33404/01/2013
    Labeler - Amerisource Bergen (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(46122-429)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(46122-429)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(46122-429)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(46122-429)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(46122-429)
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