QUALITY CHOICE GENTLE LAXATIVE (BISACODYL ) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION]

QUALITY CHOICE GENTLE LAXATIVE (BISACODYL ) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION]
PDF | XML

NDC 63868-360-08
Set ID 82426b60-53f7-4d3b-8a40-8fbcdd1c4199
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class
Product Number
Application Number PART334
  • Active ingredient

    Bisacodyl USP, 10 mg


  • Purpose

    Stimulant Laxative

  • Uses

    • For relief of occasional constipation and irregularity
    • -This product generally produces bowel movement in 15 minutes to 1 hour

  • Warnings

    For rectal use only.

  • ASK DOCTOR

    • stomach pain, nausea or vomiting
    • noticed a sudden change in bowel habits that persists over a period of two weeks

  • When using this product

    May cause abdominal discomfort, faintness, rectal burning, and mild cramps

  • STOP USE

    Stop use and ask a doctor if

    • if you have rectal bleeding or fail to have bowel movement after using a laxative. This may indicate a serious condition
    • you need to use a laxative for more than 1 week
  • PREGNANCY OR BREAST FEEDING

    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.

  • Directions

    Adults and children 12 years of age and older                           Children 6 to under 12 years                     Children under 6

    One suppository once daily                                                        1/2 suppository once daily                        Ask doctor.

    -Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum

    -Do not use more than once per day

  • Other Information

    •  do not store above 30°C (86°F)
  • Inactive Ingredients

    hydrogenated vegetable oil

  • PRINCIPAL DISPLAY PANEL

    image of display

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE GENTLE LAXATIVE 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-360
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg  in 2000 mg
    Inactive Ingredients
    Ingredient NameStrength
    FAT, HARD (UNII: 8334LX7S21) 1990 mg  in 2000 mg
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize34mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-360-082 in 1 CARTON11/16/2015
    140 mg 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 finalpart33402/13/2015
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(63868-360) , repack(63868-360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biopharm801652546manufacture(63868-360)

Related Drugs