ONELAX- bisacodyl suppository 
AKRON PHARMA INC

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.

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OneLAX
BISACODYL 10 mg Suppositories
Fast Acting Stimulant Laxative

Active Ingredients (per suppository)

Bisacodyl USP, 10  mg

Purpose

Laxative

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Warnings

For rectal use only.

Do not use laxative products

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

Other information

store below 30° C (86° F)

Inactive ingredient

hydrogenated vegetable oil

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

12pk

50pk

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)

Revised: 3/2023
Document Id: 4041f81d-086f-4825-8b50-0e1254242d84
Set id: be4eeb4d-df29-45dc-94ff-933e52c8b6f6
Version: 2
Effective Time: 20230311
 
AKRON PHARMA INC