Label: BISACODYL suppository

  • NDC Code(s): 57237-327-03, 57237-327-04, 57237-327-21, 57237-327-51
  • Packager: Rising Pharma Holdings, Inc.
  • 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 September 8, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each suppository)

    Bisacodyl USP, 10 mg

  • PURPOSE

    Purpose

    Stimulant Laxative

  • INDICATIONS & USAGE

    Use

    • for relief of occasional constipation (irregularity)
    • this product generally produces bowel movement in 15 minutes to 1 hour
  • WARNINGS

    Warnings

    For rectal use only

  • ASK DOCTOR

    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

    When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps

  • STOP USE

    Stop use and ask a doctor if

    • you need to use a laxative product for longer than one week
    • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children

    12 years of age and over

    1 suppository in a single daily dose. Peel open plastic. Insert suppository

    well into rectum, pointed end first. Retain about 15 to 20 minutes
    children 6 to under 12 years1/2 suppository in a single daily dose
    children under 6 yearsDo not use

  • STORAGE AND HANDLING

    Other information

    • store at 20-25°C (68-77°F)
    • if suppository softens prior to use, may be placed in refrigerator for short time
  • INACTIVE INGREDIENT

    Inactive ingredient hard fat

  • QUESTIONS

    Questions or Comments? Call 1-844-474-7464

  • OTHER SAFETY INFORMATION

    TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816

    Made in India

    CODE NO.: MH/DRUGS/25-KD/724

    Issued: 08/2023

  • PRINCIPAL DISPLAY PANEL

    NDC 57237-327-21 (3 blisters of 4 suppositories)

    Bisacodyl USP Suppositories 10 mg

    Stimulant Laxative

    Gentle, Predictable, Fast Relief

    DO NOT SWALLOW

    Bisc-supp-01

    NDC 57237-327-04 (4 suppositories in 1 blister pack)

    Front Foil

    Bisc-supp-02

    Back Foil

    Bisc-supp-03

  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-327
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FAT, HARD (UNII: 8334LX7S21)  
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-327-213 in 1 CARTON08/24/2023
    1NDC:57237-327-044 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:57237-327-036 in 1 CARTON08/24/2023
    2NDC:57237-327-515 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 finalpart33408/24/2023
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bliss GVS Pharma Limited675630493manufacture(57237-327) , analysis(57237-327) , pack(57237-327)
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