Label: GENTLE LAXATIVE- bisacodyl tablet

  • 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 January 6, 2022

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

View All Sections
  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Bisacodyl 5 mg

  • PURPOSE

    Purpose

    Stimulant laxative

  • INDICATIONS & USAGE

    Uses
    • relieves 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 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)
    • do not use within 1 hour after taking an antacid or milk
    • you may have stomach discomfort, faintness or cramps

    Stop use and ask a doctor if
    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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 over take 1 to 3 tablets in a single daily dose
    children 6 to under 12 years of age take 1 tablet in a single daily dose
    children under 6 years of age ask a doctor

  • OTHER SAFETY INFORMATION

    Other Information
    • each tablet contains: magnesium 5 mg
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
    • protect from excessive humidity

  • INACTIVE INGREDIENT

    Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

  • QUESTIONS

    Comments & Questions? 800-824-1706

  • PRINCIPAL DISPLAY PANEL

    014R-Winco-Gentle-lax-carton-label-24s

  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE 
    bisacodyl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-385
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GELATIN (UNII: 2G86QN327L)  
    SUCROSE (UNII: C151H8M554)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SHELLAC (UNII: 46N107B71O)  
    ACACIA (UNII: 5C5403N26O)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code TCL003
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-385-251 in 1 CARTON01/12/2022
    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 finalpart33401/12/2022
    Labeler - WinCo Foods LLC (056098817)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(67091-385)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!