Bisacodyl Laxative

Manufacturer
Medicine Shoppe International Inc
Effective date
2010-03-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:53

Label at a glance#

ProductBisacodyl Laxative
Active ingredientbisacodyl
Label structure8 sections

Indications and uses

For relief of occasional constipation This product generally produces bowel movement in 15 minutes to 1 hour

Dosage and administration

Adults and children 12 years of age and older One suppository once daily Children 6 to 12 years 1/2 suppository once daily Children under 6 Ask a doctor Detach one suppository from the strip and remove from foil Carefully insert one suppository well into the rectum Do not use more than once per day

Storage and handling

Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F). Individually sealed for your protection. Do not use if foil is torn or open.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl, 10 mg

PURPOSE

OTC - PURPOSE SECTION

Stimulant Laxative

USES

INDICATIONS & USAGE SECTION

  • For relief of occasional constipation
  • This product generally produces bowel movement in 15 minutes to 1 hour

WARNINGS

WARNINGS SECTION

For rectal use only. May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

Do not use

OTC - DO NOT USE SECTION

  • more than one per day
  • for a period of longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • if seal under product lid is torn, damaged, or open

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • if you have noticed a sudden change in bowel habits that persist over a period of two weeks
  • if you are pregnant or nursing a baby

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - WHEN USING SECTION

Stop use and ask a doctor

OTC - STOP USE SECTION

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older
One suppository once daily
Children 6 to 12 years
1/2 suppository once daily
Children under 6
Ask a doctor
  • Detach one suppository from the strip and remove from foil
  • Carefully insert one suppository well into the rectum
  • Do not use more than once per day

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
  • Individually sealed for your protection. Do not use if foil is torn or open.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

PACKAGE INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The Medicine Shoppe®

COMPARE TO ACTIVE INGREDIENT OF DULCOLAX®*

NDC 49614-133-35

Gentle Laxative

BISACODYL SUPPOSITORIES

CONSTIPATION RELIEF

8 SUPPOSITORIES 10 MG EACH

FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN PAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.

*This product is not manufactured or distributed by Boehringer Ingelhem
Pharmaceuticals, Inc., owner of the registered trademark Dulcolax®.

Another Quality Product
Distributed by Medicine Shoppe Int'l., Inc.
St. Louis, MO 63132
www.medicineshoppe.com
A Cardinal Health Company

box
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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
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
49614-133-352019-10-21C16284748780-1956f9ecf-d3aa-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49614-133-35Bisacodyl Laxative8 in 1 BOXSUPPOSITORY81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49614-133BISACODYL LAXATIVE (BISACODYL) SUPPOSITORY [MEDICINE SHOPPE INTERNATIONAL INC]1Legacy NDC, 1 package rows20100315_75133e10-f290-42be-be50-029b1367a35f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
bisacodylACTIVE INGREDIENT10X0709Y6I1
bisacodylACTIVE MOIETY10X0709Y6I1
fat, hardINACTIVE INGREDIENT8334LX7S211

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49614-13349614-133-35

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
fat, hard8334LX7S21IACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
fat, hardHARD FAT8334LX7S21CAPSULE / ORAL153 mgExact identifier — unii candidate
2 equally ranked IID candidates
fat, hardHARD FAT8334LX7S21SUPPOSITORY / RECTAL7657 mgExact identifier — unii candidate
2 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
39b6ed99-c766-4ee9-87a6-f953c0742ddc75133e10-f290-42be-be50-029b1367a35f2010-03-12WarningsExact identifier
spl id: 39b6ed99-c766-4ee9-87a6-f953c0742ddc
spl set id: 75133e10-f290-42be-be50-029b1367a35f

Reported adverse events (FAERS/openFDA)#

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