Label: BISAC-10 BISACODYL STIMULANT LAXATIVE- bisacodyl suppository

  • 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 April 28, 2023

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  • Drug Facts

  • Active ingredient (in each suppository)

    Bisacodyl 10 mg

  • Purpose

    Laxative

  • Uses

    • for relief of occasional constipation
    • this product generally produces bowel movement in 1/4 to 1 hour

  • Warnings

    For rectal use only

    Do not use
    • laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor
    • laxative products for a period longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

    When using this product
    it may cause • abdominal discomfort • faintness
                         • rectal burning              • mild cramps
                         • store at temperatures not above 86°F (30°C)

    Stop use and ask a doctor if
    • rectal bleeding
    • failure to have a bowel movement which occurs after use of a laxative may indicate a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age: 1 suppository, once daily
    • suppository should be moistened with water before inserting.

  • Other information

    • store in well closed containers

  • Inactive ingredients

    polyethylene glycol

  • Questions? +1-863-434-1782

    You may also report serious side effects to this phone number.
    Mon - Sun: 24/7

  • Bisacodyl Stimulant Laxative

    Suppositories For Adults

    FOR RECTAL USE ONLY

    Manufactured by:
    Galen Pharmaceuticals Ltd.
    334/5 GIDC Estate Waghodia,
    Vadodara, Gujarat, India, 391760

    Country of Origin: India

    Web: www.galenltd.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BISAC-10 BISACODYL STIMULANT LAXATIVE 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81440-102
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLET (Cylindrical) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81440-102-121 in 1 BOX02/15/2021
    112 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 finalpart33402/15/2021
    Labeler - GALEN PHARMACEUTICALS LIMITED (916655764)
    Establishment
    NameAddressID/FEIBusiness Operations
    GALEN PHARMACEUTICALS LIMITED916655764manufacture(81440-102)
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