Label: SIMPEX BISACODYL LAXATIVE- bisacodyl tablet, coated

  • NDC Code(s): 76457-003-00
  • Packager: Simpex Pharma Pvt. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Drug Facts


  • Active ingredient (in each tablet)

    Bisacodyl 5 mg

    Purpose

    Stimulant Laxative

  • Uses

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

    Do not use

    • if you can not 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 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 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 or overdose, get medical help orcontact a poison control center right away.

  • Directions

    • take with a glass of water.
    Adults and children 12 years and overtake 1 to 3 tablets in a single daily dose
    Children 6 to under 12 years of agetake 1 tablet in a single daily dose
    Children under 6 yearsask a doctor

  • Other information

    • preserve in well-closed containers at a temperature not exceeding 30°C 
    • avoid excessive humidity
  • Inactive ingredients

    anhydrous lactose, colloidal anhydrous silica, hypermellose, iron oxide red, iron oxide yellow, macrogol, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, povidone, sodium bicarbonate, sodiumlauryl sulfate, sodium starch glycolate type A, talc, titanium dioxide,triethyle citrate

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    SIMPEX BISACODYL LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76457-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    Colorwhite (Clear) Scoreno score
    ShapeCAPSULE (BiConvex) Size16mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76457-003-00100 in 1 CARTON; Type 0: Not a Combination Product02/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00702/09/2018
    Labeler - Simpex Pharma Pvt. Ltd (916758275)
    Establishment
    NameAddressID/FEIBusiness Operations
    Simpex Pharma Pvt. Ltd916758275manufacture(76457-003)
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