Label: BISACODYL- bisacodyl suppositories suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2025

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  • ACTIVE INGREDIENT

    Active ingredient (in each suppository)                                           Purpose
    Bisacodyl USP 10 mg.............................................................Stimulant Laxative

  • DOSAGE & ADMINISTRATION

    Uses

    - relieves occasional constipation
    - this product generally produces a bowel movement in 15 minutes 1 hour

  • Warning

    for rectal use only

    Do not usewhen abdominal pain, nausea, or vomiting are present.

  • ASK DOCTOR

    Ask a doctor before use if you havea sudden change in bowel habits that lasts over a period od 2 weeks.

  • WHEN USING

    When using this productyou may experience

    - rectal burning

    - mild cramps

    - abdominal discomfort

    - faintness

  • Stop use and ask a doctor if

    - you have rectal bleeding or you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.

    - you need to use a laxative for more than one week

  • PREGNANCY

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • MEDICATION GUIDE

    If swallowed, get medical help or contact a Poison Control Center right away.

    You may report side effects by calling Oncor Pharmaceuticals
    (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

  • Directions

    - tear off one suppository from the strip

    - peel apart the wrapper

    - continue peeling apart to almost the full length of the suppository

    - gently remove the suppository from the wrapper

    - lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out

    - retain it for 15 to 20 minutes

    - Do not exceed recommended dose

    - if suppository seems soft, place in refrigerator for a short time before use.

     Adults and children 12 years and over 1 suppository once daily
     Children 6 to under 12 years 1/2 suppository once daily
     Children under 6 years    Ask a doctor

  • Other information

    store at temperatures below 25 oC (77 oF)

  • Inactive ingredient

    hydrogenated vegetable oil

  • PURPOSE

    TAMPER EVIDENT:SUPPOSITORIES ARE WRAPPED IN TAMPER EVIDENT SEALED WRAPPERS. DO NOT USE IF WRAPPER IS TORN OR OPEN WHEN PURCHASED.

  • PRINCIPAL DISPLAY PANEL

    Oncor Pharmaceuticals

    NDC 83720-550-25

    12 Suppositories

    10 mg each

    Bisacodyl Suppositories

    Fast Acting Smulant Laxative

    Manufactured In USA For :

    Oncor Pharmaceuticals
    6755 Business Pkwy Suite 202
    Elkridge, MD 21075
    United States.

    Rev. 12/24

    Bisacodyl Suppositories

  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl suppositories suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83720-550
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    PALM KERNEL OIL (UNII: B0S90M0233)  
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83720-550-2512 in 1 CARTON; Type 0: Not a Combination Product02/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00702/01/2025
    Labeler - Oncor Pharmaceuticals (119032580)
    Registrant - Oncor Pharmaceuticals (119032580)
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