WOMENS LAXATIVE (BISACODYL) TABLET, COATED [H E B]

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WOMENS LAXATIVE (BISACODYL) TABLET, COATED [H E B]
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NDC 37808-676-11
Set ID 7a741a60-558b-4bdc-9e07-0bc572962163
Category HUMAN OTC DRUG LABEL
Packager H E B
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 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 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)
    • see end flap for expiration date and lot number 
    • avoid excessive humidity
  • 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?

    1-800-426-9391 

  • Principal Display Panel

    NDC 37808-676-11

    H-E-B®

    WOMEN'S
    LAXATIVE
    Bisacodyl USP, 5 mg

    Stimulant Laxative

    Gentle, Dependable
    Overnight Relief

    actual size

    60 TABLETS

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
    50844      REV0119A67611   

    MADE WITH PRIDE AND CARE FOR
    H-E-B®, SAN ANTONIO, TX 78204

    H-E-B®
    100%
    GUARANTEE
    promise
    If you aren't completely pleased
    with this product, we'll be happy to
    replace it or refund your money.
    You have our word on it.

    HEB 44-676A

    HEB 44-676A

  • INGREDIENTS AND APPEARANCE
    WOMENS LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-676
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-676-114 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 - H E B (007924756)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(37808-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(37808-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(37808-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(37808-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(37808-676)
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