FDA.reportPublic FDA data

Bisacodyl

Manufacturer
Padagis US LLC
Effective date
2024-10-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:42:23

Label at a glance#

ProductBisacodyl
Active ingredientBISACODYL
Label structure11 sections

Dosage and administration

adults and children 12 years of age and over 1 suppository in a single daily dose. Pull apart foil. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes. children 6 to under 12 years of age ½ suppository in a single daily dose children under 6 years of age ask a doctor

Storage and handling

• store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP 10 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Use

INDICATIONS & USAGE SECTION

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 15 minutes to 1 hour

Warnings

WARNINGS SECTION

For rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

OTC - WHEN USING SECTION

it may cause stomach discomfort, faintness, rectal burning and milk cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over

1 suppository in a single daily dose. Pull apart foil. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.

children 6 to under 12 years of age

½ suppository in a single daily dose

children under 6 years of age

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydrogenated palm kernel oil

Questions or comments?

OTC - QUESTIONS SECTION

1-866-634-9120

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0574-7050-12

Bisacodyl Suppositories, USP

10 mg

Stimulant Laxative

UNIT DOSE

12 Suppositories

carton
carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN6
198509bisacodyl 10 MG Rectal SuppositorySCD6

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
0574-7050-12Bisacodyl12 in 1 CARTONSUPPOSITORY126
0574-7050-12Bisacodyl1 in 1 BLISTER PACKSUPPOSITORY16
0574-7050-50Bisacodyl1 in 1 BLISTER PACKSUPPOSITORY16
0574-7050-50Bisacodyl50 in 1 CARTONSUPPOSITORY506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7050-12EA - Each0574-7050c123ab28-c52e-46bb-8da8-2c68be8a722512014-10-03
0574-7050-50EA - Each0574-7050b8b7568e-e63d-419b-bc81-7dad55c3874a12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6I1
BISACODYLACTIVE MOIETY10X0709Y6I1
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VP1

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
0574-70500574-7050-12, 0574-7050-50

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-10full-release2026-06-01 00:24:16

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
BisacodylBISACODYLPadagis US LLC7eada0fc-5f83-43da-a56f-b0f5372982082024-10-10WarningsExact identifier
ndc (package): 0574-7050-50
ndc (package): 0574-7050-12
ndc (product): 0574-7050
ndc11 (package): 00574705050
ndc11 (package): 00574705012
spl id: f362a4a6-01ee-46e6-941c-dad836f20029
spl set id: 7eada0fc-5f83-43da-a56f-b0f537298208

Reported adverse events (FAERS/openFDA)#

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