WOMENS LAXATIVE (BISACODYL) TABLET, COATED [WALGREEN COMPANY]

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WOMENS LAXATIVE (BISACODYL) TABLET, COATED [WALGREEN COMPANY]
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NDC 0363-0676-01, 0363-0676-52
Set ID e69c7cb7-b7da-425b-8f76-1424c8ad0a37
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART334
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  • Active ingredient (in each tablet)

    Bisacodyl 5 mg

  • Purpose

    Stimulant laxative

  • Uses

    • for relief of occasional constipation (irregularity)
    • this product generally produces bowel movement in 6 to 12 hours
  • Warnings

    Do not use

    if you are unable to swallow without chewing.

    Ask a doctor before use if you have

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

    When using this product

    • abdominal discomfort, faintness, and cramps may occur
    • do not use for a period longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    rectal bleeding or failure to have a bowel movement occurs 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 (1-800-222-1222) right away.

  • Directions

    • do not chew or crush tablets
    • do not take within 1 hour after taking an antacid or milk
    • take with water
    • adults and children 12 years and over: take 1 to 3 tablets in a single dose, once daily
    • children under 12 years: ask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous lactose, carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, methacrylic acid, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Well at
    Walgreens
    WALGREENS PHARMACIST RECOMMENDED‡

    NDC 0363-0676-52

    Women's
    Laxative
    Bisacodyl 5 mg
    Stimulant Laxative

    •Gentle, dependable
     overnight relief

    90
    TABLETS
    ENTERIC COATED

    Compare to Correctol® active ingredient‡‡

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

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    Walgreens
    100% SATISFACTION GUARANTEED
    walgreens.com ©2015 Walgreen Co.

    ‡Walgreens Pharmacist Survey Study, November 2014.

    ‡‡This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Correctol®.

    50844    ORG051567652

    Walgreens 44-676

    Walgreens 44-676

  • INGREDIENTS AND APPEARANCE
    WOMENS LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0676
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5  mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0676-526 in 1 CARTON09/16/201508/06/2021
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0676-012 in 1 CARTON09/16/201508/06/2021
    215 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 FINALpart33409/16/201508/06/2021
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(0363-0676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(0363-0676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(0363-0676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0363-0676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(0363-0676)
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