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
  • 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 11, 2023

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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 BOX11/05/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:71399-8460-550 in 1 BOX11/05/2021
    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 finalpart33411/05/2021
    Labeler - AKRON PHARMA INC (067878881)
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