Label: BISACODYL STIMULANT LAXATIVE- bisacodyl tablet, coated

  • NDC Code(s): 68163-116-25
  • Packager: Raritan Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 September 1, 2023

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  • Active ingredient (in each tablet)

    Bisacodyl, USP 5 mg

  • Purpose

    Stimulant laxative

  • Use

    ▪
    for relief of occasional constipation and irregularity
    ▪
    this product generally produces a 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

    ▪
    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 bowl 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 pregnancy 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 at (1-800-222-1222).

  • 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

    •
    store at room temperature
    •
    Protect from excessive humidity
  • Inactive ingredients

    acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow No. 10, FD&C yellow No. 6, 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 or comments?

    1-866-467-2748

  • Principal Display Panel

    NDC# 68163-116-25

    *Compare to the Active Ingredient in Dulcolax® Tablets

    Bisacodyl Laxative

    Bisacodyl, USP 5 mg/Stimulant Laxative

    Gentle, Overnight relief constipation relief

    25 Coated Tablets

    *This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Dulcolax® Tablets.

    TAMPER EVIDENT: Do not use if any individual unit is broken or open.

    IMPORTANT: Keep this carton for future reference on full labeling.

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court,

    East Brunswick, NJ 08816

    DRx Choice Bisacodyl Laxative
  • INGREDIENTS AND APPEARANCE
    BISACODYL  STIMULANT LAXATIVE
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-116
    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)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code RP116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-116-251 in 1 CARTON10/29/2019
    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 finalpart33410/29/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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