DULCOLAX STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CHATTEM, INC.]

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DULCOLAX STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CHATTEM, INC.]
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NDC 41167-0400-1, 41167-0400-2, 41167-0400-3, 41167-0400-4, 41167-0400-5, 41167-0400-6, 41167-0400-8
Set ID f1e4b28a-ed74-4eff-bd10-b2bfaf7483b0
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number PART334
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  • SPL UNCLASSIFIED SECTION

    Dulcolax Stimulant Laxative Tablets

    Drug Facts

  • Active ingredient (in each tablet)

    Bisacodyl (USP) 5 mg

  • Purpose

    Stimulant laxative

  • Use

    ● for 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

    ● noticed a sudden change in bowel habits that lasts more than 2 weeks

    When using this product

    ● it may cause stomach discomfort, faintness and cramps

    ● do not chew or crush tablet(s)

    ● do not use within 1 hour after taking an antacid or milk

    Stop use and ask a doctor if

    ● you have rectal bleeding or fail to have a 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.

  • Directions

    take with a glass of water

    adults and children 12 years of age and over                   1 to 3 tablets in a single daily dose

    children 6 to under 12 years of age                         1 tablet in a single daily dose

    children under 6 years of age                               ask a doctor

  • Other information

    ● contains FD&C Yellow No. 6

    ● do not use if individual blister unit is open or torn

    ● store at 20°-25°C (68°-77°F)  

    ● protect from excessive humidity

  • Inactive ingredients

    acacia senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions?

    Call 1-866-844-2798 or visit www.Dulcolax.com

    Keep carton as it contains important product information.

  • PRINCIPAL DISPLAY PANEL

    Dulcolax
    LAXATIVE
    200 TABLETS

    PRINCIPAL DISPLAY PANEL Dulcolax LAXATIVE 200 TABLETS

  • INGREDIENTS AND APPEARANCE
    DULCOLAX STIMULANT LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0400
    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 CARBONATE (UNII: H0G9379FGK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code DU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0400-51 in 1 CARTON04/14/2019
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0400-68 in 1 CARTON04/14/2019
    225 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-0400-83 in 1 CARTON05/01/2019
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:41167-0400-32 in 1 CARTON04/14/2019
    425 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:41167-0400-21 in 1 CARTON04/14/2019
    525 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:41167-0400-11 in 1 CARTON04/14/2019
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:41167-0400-44 in 1 CARTON06/03/2019
    725 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 FINALpart33404/14/2019
    Labeler - Chattem, Inc. (003336013)
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