Label: ONELAX- bisacodyl suppository

  • NDC Code(s): 71399-8460-2, 71399-8460-5
  • Packager: AKRON PHARMA INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 20, 2024

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  • 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

    Manufactured for:
    Akron Pharma Inc.,
    Fairfield, NJ-07004
    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    12pk

    50pk

  • INGREDIENTS AND APPEARANCE
    ONELAX 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8460
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FAT, HARD (UNII: 8334LX7S21)  
    Product Characteristics
    Colorwhite (WHITE TO OFF WHITE) Score    
    ShapeOVAL (TORPEDO SHAPE) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-8460-212 in 1 BOX09/13/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:71399-8460-550 in 1 BOX09/13/2024
    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 DrugM00709/13/2024
    Labeler - AKRON PHARMA INC (067878881)
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