Label: BET-R-PREP BISACODYL- bisacodyl tablet

  • NDC Code(s): 71890-330-25
  • Packager: Satius Pharmaceuticals, LLC
  • 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 October 31, 2019

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  • Drug Facts

  • Active ingredient (in each tablet)

    Bisacodyl 5 mg 

    Purpose

    Stimulant Laxative

  • Uses

    • relieves occasional constipation and irregularity
    • this product generally produces a bowel movement in 6 to 12 hours
  • Warnings

    Do not use

    • for more than one week unless directed by a doctor
    • if you cannot swallow without chewing
    • within 1 hour after taking an antacid or milk

    Ask a doctor before use if you have

    • abdominal pain
    • nausea
    • vomiting
    • a sudden change in bowel habits that lasts longer than 2 weeks

    When using this product

    •  abdominal discomfort, faintness, or cramps may occur

    Stop use and ask a doctor

    • if you have no bowel movement within 12 hours
    • if you have rectal bleeding
    • these could be signs of a serious condition

    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

    • do not take more than directed
    • swallow whole, do not chew or crush
    • take recommended dose in a single daily dose
    • take with water
    • adults and children 12 years and older: take 1-3 (usually 2) tablets daily
    • chidren 12 and under: ask a doctor
  • Other information

    • store at room temperature
    • avoid excessive humidity
  • 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 or Comments?

    contact us at:

    732-430-2208

    www.satiusrx.com

  • Package Labeling:

    Package label

  • INGREDIENTS AND APPEARANCE
    BET-R-PREP BISACODYL 
    bisacodyl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71890-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize1mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71890-330-251 in 1 BOX11/18/2017
    125 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/18/2017
    Labeler - Satius Pharmaceuticals, LLC (080518631)
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