Label at a glance#

ProductOneLAX

Active ingredientBISACODYL

Label structure14 sections

Indications and uses

for relief of occasional constipation this product usually produces bowel movement in 1/4 to 1 hour

Dosage and administration

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

Contacts and useful links#

Websitewww.akronpharma.com

www.akronpharma.com

Label contents#

Full prescribing information#

Active Ingredients (per suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP, 10 mg

Purpose

OTC - PURPOSE SECTION

Laxative

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

for relief of occasional constipation
this product usually produces bowel movement in 1/4 to 1 hour

Warnings

WARNINGS SECTION

For rectal use only.

Do not use laxative products

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

noticed a sudden change in bowel habits that persist over a period of 2 weeks

When using this product

OTC - WHEN USING SECTION

it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

store below 30° C (86° F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12pk

50pk

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198509	bisacodyl 10 MG Rectal Suppository	PSN	4
198509	bisacodyl 10 MG Rectal Suppository	SCD	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEACETYLBISACODYL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71399-8460-2	2024-09-20	C162847	48780-1	1e7a6dab-1758-a2ce-e063-dadaa90aadf7	OneLAX BISACODYL 10 mg Suppositories Fast Acting Stimulant Laxative
71399-8460-2	2024-09-20	C162847	48780-1	1e7a6dab-1758-a2ce-e063-dadaa90aadf7	OneLAX BISACODYL 10 mg Suppositories Fast Acting Stimulant Laxative
71399-8460-5	2024-09-20	C162847	48780-1	1e7a6dab-1758-a2ce-e063-dadaa90aadf7	OneLAX BISACODYL 10 mg Suppositories Fast Acting Stimulant Laxative
71399-8460-5	2024-09-20	C162847	48780-1	1e7a6dab-1758-a2ce-e063-dadaa90aadf7	OneLAX BISACODYL 10 mg Suppositories Fast Acting Stimulant Laxative
71399-8460-2	2024-07-30	C162847	48780-1	1e7a6dab-1758-a2ce-e063-dadaa90aadf7	OneLAX BISACODYL 10 mg Suppositories Fast Acting Stimulant Laxative
71399-8460-2	2024-07-30	C162847	48780-1	1e7a6dab-1758-a2ce-e063-dadaa90aadf7	OneLAX BISACODYL 10 mg Suppositories Fast Acting Stimulant Laxative
71399-8460-5	2024-07-30	C162847	48780-1	1e7a6dab-1758-a2ce-e063-dadaa90aadf7	OneLAX BISACODYL 10 mg Suppositories Fast Acting Stimulant Laxative
71399-8460-5	2024-07-30	C162847	48780-1	1e7a6dab-1758-a2ce-e063-dadaa90aadf7	OneLAX BISACODYL 10 mg Suppositories Fast Acting Stimulant Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71399-8460-2	OneLAX	1 in 1 BLISTER PACK	SUPPOSITORY	1	4
71399-8460-2	OneLAX	12 in 1 BOX	SUPPOSITORY	12	4
71399-8460-5	OneLAX	50 in 1 BOX	SUPPOSITORY	50	4
71399-8460-5	OneLAX	1 in 1 BLISTER PACK	SUPPOSITORY	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71399-8460-2	EA - Each	71399-8460	973def14-1a56-4c0d-801c-477693cc4a03	1	2021-12-08
71399-8460-5	EA - Each	71399-8460	102289e2-cc58-4793-9fca-b8c4be2c7e2b	1	2022-12-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

OneLAX
BISACODYL
FAT, HARD
DEACETYLBISACODYL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71399-8460	71399-8460-2, 71399-8460-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FAT, HARD	8334LX7S21	IACT
BISACODYL	10X0709Y6I	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2024-09-20	full-release	2026-06-01 00:19:58

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OneLAX	BISACODYL	AKRON PHARMA INC	be4eeb4d-df29-45dc-94ff-933e52c8b6f6	2025-11-03	Warnings	Exact identifier ndc (package): 71399-8460-5 ndc (package): 71399-8460-2 ndc (product): 71399-8460 ndc11 (package): 71399846005 ndc11 (package): 71399846002 spl id: 42b7c75d-d66d-77f9-e063-6294a90a4e40 spl set id: be4eeb4d-df29-45dc-94ff-933e52c8b6f6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.