Label: BISACODYL tablet, coated

  • NDC Code(s): 69618-058-01
  • Packager: RELIABLE 1 LABORATORIES LLC
  • 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 November 1, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Bisacodyl 5 mg

  • PURPOSE

    Purpose

    Stimulant Laxative

  • INDICATIONS & USAGE

    Uses

    • for relief of occasional constipation and irregularity
    • this product generally produces bowel movement in 6 to 12 hours
  • WARNINGS

    Warnings

    Do not use if you cannot swallow without chewing.

    Ask a doctor before use if you have

    • stomach pain, nausea, vomiting
    • noticed a sudden change in bowel habits that lasts more than 2 weeks

    When using this product

    • do not chew or crush tablet(s)
    • do not use within 1 hour after taking an antacid or milk
    • it may cause stomach discomfort, faintness and cramps

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • take with a glass of water
    • adults and children 12 years and older: take 1 to 3 tablets in a single daily dose
    • children 12 and under: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
    • store at room temperature15°-30°C (59°-86°F)
    • avoid excessive humidity
    • package not child resistant
  • INACTIVE INGREDIENT

    Inactive ingredients: Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D&C Yellow #10 Lake, FD&C Yellow #6 Lake, Hypromellose, Iron Oxide Black, Lactose, Magnesium Stearate, Methylparaben, PEG, Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben, Propylene Glycol, Povidone, Shellac, Simethicone, Silica, Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate,
    Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin,Triethyl Citrate, Wax.

  • QUESTIONS

    Questions or comments? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reliable-1 Laboratories, LLC

    Valley Stream, NY 11580

    www.reliable1labs.com

    *This product is not manufactured or distributed by the owner of the registered trademark Dulcolax®

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    ACACIA (UNII: 5C5403N26O)  
    AMMONIA (UNII: 5138Q19F1X)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-058-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2020
    Labeler - RELIABLE 1 LABORATORIES LLC (079718111)