Bisacodyl

Manufacturer
Oncor Pharmaceuticals
Effective date
2025-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:07

Label at a glance#

ProductBisacodyl
Active ingredientBISACODYL
Label structure14 sections

Dosage and administration

- tear off one suppository from the strip - peel apart the wrapper - continue peeling apart to almost the full length of the suppository - gently remove the suppository from the wrapper - lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out - retain it for 15 to 20 minutes - Do not exceed recommended dose - if suppository seems soft, place in refrigerator for ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)                                           Purpose
Bisacodyl USP 10 mg.............................................................Stimulant Laxative

DOSAGE & ADMINISTRATION SECTION

Uses

- relieves occasional constipation
- this product generally produces a bowel movement in 15 minutes 1 hour

Warning

WARNINGS SECTION

for rectal use only

Do not usewhen abdominal pain, nausea, or vomiting are present.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you havea sudden change in bowel habits that lasts over a period od 2 weeks.

OTC - WHEN USING SECTION

When using this productyou may experience

- rectal burning

- mild cramps

- abdominal discomfort

- faintness

Stop use and ask a doctor if

OTC - STOP USE SECTION

- you have rectal bleeding or you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.

- you need to use a laxative for more than one week

PREGNANCY SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL MEDGUIDE SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

You may report side effects by calling Oncor Pharmaceuticals
(9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Directions

INDICATIONS & USAGE SECTION

- tear off one suppository from the strip

- peel apart the wrapper

- continue peeling apart to almost the full length of the suppository

- gently remove the suppository from the wrapper

- lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out

- retain it for 15 to 20 minutes

- Do not exceed recommended dose

- if suppository seems soft, place in refrigerator for a short time before use.

 Adults and children 12 years and over 1 suppository once daily
 Children 6 to under 12 years 1/2 suppository once daily
 Children under 6 years    Ask a doctor

Other information

OTHER SAFETY INFORMATION

store at temperatures below 25 oC (77 oF)

Inactive ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

OTC - PURPOSE SECTION

TAMPER EVIDENT:SUPPOSITORIES ARE WRAPPED IN TAMPER EVIDENT SEALED WRAPPERS. DO NOT USE IF WRAPPER IS TORN OR OPEN WHEN PURCHASED.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oncor Pharmaceuticals

NDC 83720-550-25

12 Suppositories

10 mg each

Bisacodyl Suppositories

Fast Acting Smulant Laxative

Manufactured In USA For :

Oncor Pharmaceuticals
6755 Business Pkwy Suite 202
Elkridge, MD 21075
United States.

Rev. 12/24

Bisacodyl SuppositoriesBisacodyl Suppositories

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN1
198509bisacodyl 10 MG Rectal SuppositorySCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEACETYLBISACODYL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83720-550-25Bisacodyl12 in 1 CARTONSUPPOSITORY121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83720-550BISACODYL (BISACODYL SUPPOSITORIES) SUPPOSITORY [ONCOR PHARMACEUTICALS]1Current NDC, 1 package rows20250201_6f0aefc9-cd5f-4bdd-89c2-b6a80558987c.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83720-55083720-550-25

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
NameUNIIKind
PALM KERNEL OILB0S90M0233IACT
BISACODYL10X0709Y6IACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
ndc (package): 83720-550-25
ndc (product): 83720-550
ndc11 (package): 83720055025
spl id: 2c74d37c-18ff-b903-e063-6294a90a51dc
spl set id: 6f0aefc9-cd5f-4bdd-89c2-b6a80558987c

Reported adverse events (FAERS/openFDA)#

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