Label: DULCOLAX- bisacodyl tablet, coated

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 4, 2011

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  • Drug Facts

    Active ingredient (in each tablet)Purpose
    Bisacodyl USP 5 mg .................................... 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.

  • Directions

    take with a glass of water

    adults and children 12 years of age and over1 to 3 tablets in a single daily dose
    children 6 to under 12 years of age1 tablet in a single daily dose
    children under 2 years of ageask a doctor
  • Other information

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

    acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake

  • PRINCIPAL DISPLAY PANEL

    Dulcolax (bisacodyl USP) laxative tablets

    5 mg

    NDC 54868-0016-0

    image of package label

  • INGREDIENTS AND APPEARANCE
    DULCOLAX 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0016(NDC:0597-0012)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bisacodyl (UNII: 10X0709Y6I) (bisacodyl - UNII:10X0709Y6I) bisacodyl5 mg
    Inactive Ingredients
    Ingredient NameStrength
    acacia (UNII: 5C5403N26O)  
    carnauba wax (UNII: R12CBM0EIZ)  
    cellacefate (UNII: F2O5O2OI9F)  
    starch, corn (UNII: O8232NY3SJ)  
    dibutyl phthalate (UNII: 2286E5R2KE)  
    docusate sodium (UNII: F05Q2T2JA0)  
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    kaolin (UNII: 24H4NWX5CO)  
    lactose (UNII: J2B2A4N98G)  
    magnesium stearate (UNII: 70097M6I30)  
    methylparaben (UNII: A2I8C7HI9T)  
    shellac (UNII: 46N107B71O)  
    polyethylene glycol (UNII: 3WJQ0SDW1A)  
    povidone (UNII: FZ989GH94E)  
    propylparaben (UNII: Z8IX2SC1OH)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitan monooleate (UNII: 06XEA2VD56)  
    sucrose (UNII: C151H8M554)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    white wax (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code 12;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-0016-01 in 1 CARTON
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/19/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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