Label: 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 July 14, 2014

If you are a consumer or patient please visit this version.

  • Drug Facts Active Ingredients (per suppository)

    Bisacodyl USP, 10  mg

  • Purpose

    Laxative

  • 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.

  • Uses

    • for relief of occasional constipation
    • this product usually 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
    • for a period longer than one week
  • Ask a doctor before use if you have

    noticed a sudden change in bowel habits that persist over a period of 2 weeks

  • When using this product

    it may cause abdominal discomfort, faintness, rectal burning and mild cramps

  • Stop use and ask a doctor if

    rectal bleeding occurs, or you fail to have a bowel movement after using a laxative. This may indicate a serious condition.

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Directions

    • adults and children 12 years of age and older
    • detach one suppository from the strip
    • remove from wrapper before inserting into the rectum
    • the rectal suppository dose is one suppository per day or as directed by a doctor
    • children under 12 years of age consult a doctor
  • Other information

    store below 30° C (86° F)

  • Inactive ingredient

    hydrogenated vegetable oil

  • BISACODYL Laxative Suppository Label

    Acino Products

    NDC 68784-102-16

    COMPARE TO THE ACTIVE INGREDIENT IN DULCOLAX® SUPPOSITORIES

    BISACODYL
    Laxative Suppositories

    FAST RELIEF OF TEMPORARY CONSTIPATION OFTEN IN 15 MINUTES TO 1 HOUR

    16 SUPPOSITORIES (10 mg each)

    TAMPER-EVIDENT: FOR YOUR SAFETY, SUPPOSITORIES ARE PACKED IN TAMPER-EVIDENT SEALED WRAPPER.
    DO NOT USE IF WRAPPER IS TORN OR OPEN.

    This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare Products, Inc., owner of the registered trademark Dulcolax®

    DISTRIBUTED BY
    ACINO PRODUCTS, LLC
    681 MAIN ST. BLDG. 27
    BELLEVILLE, NJ 07109

    MADE IN USA

    Acino Bisacodyl Label


  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68784-102
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FAT, HARD (UNII: 8334LX7S21)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68784-102-088 in 1 BOX
    11 in 1 BLISTER PACK
    2NDC:68784-102-1212 in 1 BOX
    21 in 1 BLISTER PACK
    3NDC:68784-102-1616 in 1 BOX
    31 in 1 BLISTER PACK
    4NDC:68784-102-01100 in 1 BOX
    41 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2005
    Labeler - Acino Products, LLC (019385518)
    Registrant - Acino Products, LLC (019385518)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acino Products, LLC019385518manufacture(68784-102)