Bisacodyl

Manufacturer
CARDINAL HEALTH, INC. | G&W Laboratories, Inc.
Effective date
2012-03-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:47:29

Label at a glance#

ProductBisacodyl
Active ingredientBisacodyl
Label structure10 sections

Indications and uses

For the relief of occasional constipation. Bowel movement is generally produced in 15 minutes to 1 hour.

Dosage and administration

• Remove foil. Insert suppository well into rectum touching the bowel wall. Retain about 15 to 20 minutes.      • In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with petroleum jelly.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP, 10 mg

PURPOSE

OTC - PURPOSE SECTION

Laxative

USES

INDICATIONS & USAGE SECTION

For the relief of occasional constipation. Bowel movement is generally produced in 15 minutes to 1 hour.

WARNINGS

WARNINGS SECTION

For rectal use only

Do not use
laxative products for a period longer than one week unless directed by a doctor

Ask a doctor before use if you have
• abdominal pain, nausea or vomiting
• a sudden change in bowel habits that lasts longer than 2 weeks

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN SECTION

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

• Remove foil. Insert suppository well into rectum touching the bowel wall. Retain about 15 to 20 minutes.
     Direction ChartDirection Chart
• In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with petroleum jelly.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Store at room temperature

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-102-53
LEADER®
BISACODYL SUPPOSITORIES
LAXATIVE
FOR PROMPT RELIEF OF CONSTIPATION
12 BISACODYL SUPPOSITORIES 10 MG EACH
Compare to Dulcolax® active ingredient*
Satisfaction Guaranteed

Unit Carton
Unit Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-102-532025-04-03C16284748780-19d75b9d0-87d6-f424-e053-dadaa90a57ceBisacodyl Suppositories
37205-102-532020-01-31C16284748780-19d75b9d0-87d6-f424-e053-dadaa90a57ceBisacodyl Suppositories

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-102-53EA - Each37205-1026470655f-9999-42db-92ef-5001c1b7d28612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BisacodylACTIVE INGREDIENT10X0709Y6I2
BisacodylACTIVE MOIETY10X0709Y6I2
Hydrogenated Palm Kernel OilINACTIVE INGREDIENTFM8D1RE2VP2

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
37205-10237205-102-53

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 Palm Kernel OilFM8D1RE2VPIACT

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
c6798bd1-561a-4634-8b38-5e8b9b6a402aaf84c8aa-02fa-758f-0072-2eedf60e68ae2025-04-03WarningsExact identifier
spl set id: af84c8aa-02fa-758f-0072-2eedf60e68ae

Reported adverse events (FAERS/openFDA)#

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