UP AND UP GENTLE LAXATIVE (BISACODYL) TABLET, COATED [TARGET CORPORATION]

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UP AND UP GENTLE LAXATIVE (BISACODYL) TABLET, COATED [TARGET CORPORATION]
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NDC 11673-116-25
Set ID 4a29dc2b-b68f-471b-a84e-4a5096aa3748
Category HUMAN OTC DRUG LABEL
Packager Target Corporation
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)
    ▪
    it may cause stomach discomfort, faintness and cramps
    ▪
    do not use within 1 hour after taking an antacid or milk

    Stop use and ask a doctor if

    ▪
    you have rectal bleeding or no bowel movement after using this product.  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 right away. (1-800-222-1222)

  • Directions

    take with a glass of water

     adults and children 12 years of age and over

     take 1 to 3 tablets in a single daily dose

     children 6 to under 12 years of age

     take 1 tablet in a single daily dose

     children under 6 years of age

     ask a doctor
  • Other information

    •
    store at 20°-25°C (68°-77°F)
    •
    Protect from excessive humidity
  • Inactive ingredients

    acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG)400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

    Questions?

    Call 1-800-910-6874

  • Principal Display Panel

    NDC 11673-116-25

    Compare to active ingredient in Dulcolax®*

    gentle laxative tablets

    bisacodyl USP, 5 mg

    gentle,overnight relief of constipation

    25 Tablets

    25 COATED TABLETS

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

    245 05 0371 R00 ID295403

    Dist.by Target Corp., Mpls., MN 55403

    ©2015 Target Brands, Inc.

    Shop Target.com

    TAMPER- EVIDENT: DO NOT USE IF ANY INDIVIDUAL UNIT IS BROKEN OR OPEN

    up and up gentle laxative tablets
  • INGREDIENTS AND APPEARANCE
    UP AND UP GENTLE LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-116
    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)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUND (Bi-convex) Size6mm
    FlavorImprint Code TCL003
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-116-251 in 1 CARTON09/14/2015
    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 finalpart33409/14/2015
    Labeler - Target Corporation (006961700)
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