Label: PROCTOZONE-B- bisacodyl suppository

  • NDC Code(s): 57237-337-03, 57237-337-04, 57237-337-21, 57237-337-51
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 22, 2024

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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, INDIVIVIDUALLY SEALED FOR YOUR PROTECTION

  • SPL UNCLASSIFIED SECTION

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

    Made in India

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

    Issued: 09/2024

  • PRINCIPAL DISPLAY PANEL

    NDC 57237-337-21 (3 blisters of 4 suppositories)

    Proctozone-BTM

    Bisacodyl (USP) 10 mg Suppositories 

    MEDICATED LAXATIVE SUPPOSITORY

    Gentle, Predictable Relief

    DO NOT SWALLOW

    Proctozone-B-supp-01

    NDC 57237-337-04 (4 suppositories in 1 blister pack)

    Front Foil

    Proctozone-B-supp-02

    NDC 57237-337-04 (4 suppositories in 1 blister pack)

    Back Foil

    Proctozone-B-supp-03

  • INGREDIENTS AND APPEARANCE
    PROCTOZONE-B 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-337
    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:57237-337-213 in 1 CARTON12/01/2024
    1NDC:57237-337-044 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:57237-337-036 in 1 CARTON02/01/2025
    2NDC:57237-337-515 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM007.6012/01/2024
    Labeler - Rising Pharma Holdings, Inc. (116880195)
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