Label: PREMIER VALUE BISACODYL LAXATIVE- bisacodyl suppository 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 March 25, 2015

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

  • Active Ingredient (in each Suppository)

    Active Ingredient (in each Suppository)        Purpose

    Bisacodyl USP, 10 mg.................................Laxative

  • Uses

    Uses - For relief of occasional constipation -this product generally produces bowel movement in 1/4 hour to 1 hour 

  • Warnings

    For rectal use only.

  • Do not use

    Do not use laxative products

    -when abdominal pain, nausea, or vomiting are present - for a period longer than 1 week

  • Ask a doctor before use if you have

    Ask a doctor before use if you have noticed a sudden change in bowel movement

    burning and mild cramps

  • When using this product

    When using this product it may cause abdominal discomfort, faintness, rectal burning, and mild cramps

  • Stop use and ask a doctor

    Stop use and ask a doctor if rectal bleeding occurs, or you fail to have bowel movement after using a laxative.  This may indicate a serious condition.

  • If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a 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.

  • 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

    Other information

    store below 30oC (86oF)

  • Inactive ingredient

    Inactive ingredient  

    hydrogenated vegetable oil

  • Purpose

    Active Ingredient (in each Suppository)         Purpose
    Bisacodyl USP, 10 mg.................................Laxative

  • Product Label

    Product Label

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE BISACODYL LAXATIVE 
    bisacodyl suppository suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-306
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL10 mg  in 2000 mg
    Inactive Ingredients
    Ingredient NameStrength
    PALM KERNEL OIL (UNII: B0S90M0233) 1990 mg  in 2000 mg
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize32mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-306-092 in 1 PACKAGE
    1NDC:68016-306-0840 mg in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/25/2015
    Labeler - Chain Drug Consortium (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(68016-306)