Label: GENTLE LAXATIVE- biisacodyl tablet, coated

  • 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 February 15, 2012

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  • Active ingredient (in each tablet)

    Bisacodyl USP 5 mg

  • Purpose

    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)
    • 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.

  • 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 20° - 25°C (68° - 77°F)
    • protect from excessive humidity
    • blister packaged for your protection. Do not use if individual seals are broken.
  • Inactive ingredients

    acacia, carnauba wax, corn starch, gelatin, glycerin esters of fatty acids, hypromellose phthalate 200731, lactose hydrate, magnesium stearate, polyethylene glycol 400, povidone, precipitated calcium carbonate, sucrose, talc, titanium oxide, yellow no. 4

  • Package label

    Gentle Laxativeimage of carton label

  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE 
    biisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0171
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code BIS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0171-22 in 1 BOX
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/15/2012
    Labeler - Kareway Product, Inc. (121840057)
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