WOMENS LAXATIVE (BISACODYL) TABLET, COATED [BETTER LIVING BRANDS, LLC]

WOMENS LAXATIVE (BISACODYL) TABLET, COATED [BETTER LIVING BRANDS, LLC]
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NDC 21130-676-01
Set ID ee455662-fa7f-43bc-af3d-302e240ac5ce
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART334
  • 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 yearsask a doctor

  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • avoid excessive humidity
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • 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?

    1-800-426-9391 

  • Principal Display Panel

    Signature
    care

    Quality Guaranteed

    NDC 21130-676-01

    Women's
    Laxative

    BISACODYL USP, 5 mg
    Stimulant Laxative

    • For gentle, dependable
    constipation relief
    • Comfort coated
    tablets

    Actual Size

    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
    BETTER LIVING BRANDS LLC
    P.O. BOX 99
    PLEASANTON, CA 94566-0009
    1-888-723-3929
    www.betterlivingbrandsLLC.com

    OUR PROMISE
    QUALITY & SATISFACTION
    100% GUARANTEED
    OR YOUR MONEY BACK

    Signature Care 44-676A

    Signature Care 44-676A

  • INGREDIENTS AND APPEARANCE
    WOMENS LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-676
    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)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    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:21130-676-012 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 - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(21130-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(21130-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(21130-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(21130-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(21130-676)

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