WOMENS LAXATIVE (BISACODYL) TABLET, COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.]

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WOMENS LAXATIVE (BISACODYL) TABLET, COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.]
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NDC 64092-121-30
Set ID 84cc2a8c-92d0-4165-962d-563abed6d752
Category HUMAN OTC DRUG LABEL
Packager GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
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 relief of occasional constipation (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

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

    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 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 over
    		take 1 to 3 tablets in a
    single daily dose
    children 6 to under 12
    years
    		take 1 tablet in a single
    daily dose
    children under 6 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)
    • avoid excessive humidity
    • see end flap for expiration date and lot number 
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-800-426-9391 

  • Principal Display Panel

    HEALTHCARE ™

    NDC 64092-121-30

    Women's Laxative
    Bisacodyl USP, 5 mg
    Stimulant Laxative

    A gentle action feminine laxative

    Gentle, Dependable
    Constipation Relief

    EACH ENTERIC COATED
    TABLET CONTAINS
    5 mg BISACODYL

    30  TABLETS

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

    50844   REV0119A67601

    Distributed by:
    Great Lakes Wholesale & Marketing L.L.C.
    3729 Patterson Ave., S.E.,
    Grand Rapids, MI 49512
    www.glwholesale.com

    HEALTHCARE GUARANTEE
    If you are not completely satisfied
    with this product, regardless of reason,
    return your unused portion to
    Great Lakes Wholesale for a full refund

    Healthcare 44-676A

    Healthcare 44-676A

  • INGREDIENTS AND APPEARANCE
    WOMENS LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-121
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-121-302 in 1 CARTON09/16/2015
    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 FINALpart33409/16/2015
    Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(64092-121)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(64092-121)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(64092-121)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(64092-121)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(64092-121)
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