Label: BISACODYL suppository

  • NDC Code(s): 0574-7050-12, 0574-7050-50
  • Packager: Paddock Laboratories, LLC
  • 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 2, 2019

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

  • Active ingredient (in each suppository)

    Bisacodyl USP 10 mg

  • Purpose

    Stimulant laxative

  • Use

    for temporary relief of occasional constipation and irregularity
    this product generally produces bowel movement in 15 minutes to 1 hour
  • Warnings

    For rectal use only

    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

    Ask a doctor or pharmacist before use if you are

    taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    When using this product

    it may cause stomach discomfort, faintness, rectal burning and milk cramps

    Stop use and ask a doctor if

    you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition
    you need to use a laxative for more than 1 week
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    adults and children 12 years of age and over

    1 suppository in a single daily dose. Pull apart foil. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.

    children 6 to under 12 years of age

    ½ suppository in a single daily dose

    children under 6 years of age

    ask a doctor

  • Other information

    store at 20-25°C (68-77°F)
  • Inactive ingredients

    hydrogenated vegetable oil

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    NDC 0574-7050-12

    Bisacodyl Suppositories, USP

    10 mg

    Stimulant Laxative

    Easy-open plastic packets

    Tapered shape for easy insertion

    UNIT DOSE

    12 Suppositories

    bisacodyl
  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0574-7050
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    COTTONSEED OIL (UNII: H3E878020N)  
    Product Characteristics
    ColorWHITE (white to cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0574-7050-1212 in 1 CARTON09/01/1990
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0574-7050-5050 in 1 CARTON09/01/1990
    21 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 finalpart33409/01/1990
    Labeler - Paddock Laboratories, LLC (967694121)