BISACODYL

Manufacturer
Geritrex Corp.
Effective date
2012-02-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:31:24

Label at a glance#

ProductBISACODYL
Active ingredientBISACODYL
Label structure9 sections

Indications and uses

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

Dosage and administration

tear off one suppository from the strip. tear and peel the wrapper in downward motion. continue tearing downward to almost the full length of the suppository (see illustration at the right) 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 suppo...

Storage and handling

store at temperatures below 30'C (86'F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)                   Purpose

Bisacodyl USP 10 mg ................................      Stimulant laxative

Uses

OTC - PURPOSE SECTION

relieves occasional constipation.

this product generally produces a bowel movement in 15 minutes to 1 hour.

Directions

INDICATIONS & USAGE SECTION


tear off one suppository from the strip.
tear and peel the wrapper in downward motion.
continue tearing downward to almost the full length of the suppository (see illustration at the right)
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 under 12 years                        Ask a doctor.

DOSAGE & ADMINISTRATION SECTION


Adults and children 12 years and over   1 suppository once daily.
Children under 12 years                        Ask a doctor.

WARNINGS

WARNINGS SECTION

For rectal use only.

Do not use when abdominal pain, nausea, or vomiting are present.

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

When using this product you may experience. rectal burning. mild cramps.abdominal discomfort. faintness.

stop use and ask a doctor if you have rectal bleeding. you fill 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.

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

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION


hydrogenated vegetable oil

STORAGE

STORAGE AND HANDLING SECTION

store at temperatures below 30'C (86'F)

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label of BoxLabel of BoxEnter section text here

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN3
198509bisacodyl 10 MG Rectal SuppositorySCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISACODYL Pharmacologic Class Indexing1Indexing - Pharmacologic Class20101101

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-006-122019-11-13C16284748780-197449f38-ce24-f6ea-e053-dbdaa90aa703Bisacodyl Suppositories

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-006-12BISACODYL2 g in 1 BOX, UNIT-DOSESUPPOSITORY23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-006BISACODYL SUPPOSITORY [GERITREX CORP.]3Legacy NDC, 1 package rows20120413_933a409e-09de-42f4-ab93-f47d05ced4b8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-006-01EA - Each54162-006aa1f32e0-c15c-4bc0-8db5-553c44cbffef12012-07-24
54162-006-12EA - Each54162-0065606a3c7-1ef7-461c-9687-9a86ccdc61a912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6I3
BISACODYLACTIVE MOIETY10X0709Y6I3
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918C3

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54162-00654162-006-12

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
BISACODYL10X0709Y6IACTIB
HYDROGENATED SOYBEAN OILA2M91M918CIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROGENATED SOYBEAN OILHYDROGENATED SOYBEAN OILA2M91M918CTABLET, COATED / ORAL3 mgExact identifier — unii candidate
4 equally ranked IID candidates
HYDROGENATED SOYBEAN OILHYDROGENATED SOYBEAN OILA2M91M918CTABLET, EXTENDED RELEASE / ORAL96 mgExact identifier — unii candidate
4 equally ranked IID candidates
HYDROGENATED SOYBEAN OILHYDROGENATED SOYBEAN OILA2M91M918CCAPSULE / ORAL95 mgExact identifier — unii candidate
4 equally ranked IID candidates
HYDROGENATED SOYBEAN OILHYDROGENATED SOYBEAN OILA2M91M918CTABLET / ORAL13.5 mgExact identifier — unii candidate
4 equally ranked IID candidates

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
63a99d4b-5b19-41c8-88d8-6582011e4ec7933a409e-09de-42f4-ab93-f47d05ced4b82012-02-23WarningsExact identifier
spl id: 63a99d4b-5b19-41c8-88d8-6582011e4ec7
spl set id: 933a409e-09de-42f4-ab93-f47d05ced4b8

Reported adverse events (FAERS/openFDA)#

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