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Gentle Laxative (Kareway Product, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 2 BLISTER PACK in 1 BOX (67510-0171-2) > 10 TABLET, COATED in 1 BLISTER PACK Label Information

Complete Gentle Laxative Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0171
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color yellow Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code BIS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0171-2 2 in 1 BOX
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 02/15/2012
    Labeler - Kareway Product, Inc. (121840057)