FDA.reportPublic FDA data

Dulcolax Laxative

Manufacturer
Chattem, Inc.
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:26

Label at a glance#

ProductDulcolax Laxative
Active ingredientBISACODYL
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dulcolax®

Medicated Laxative Suppositories

Drug Facts

Active ingredient (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl (USP) 10 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For rectal use onlyFor rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Peel open plastic. Insert suppository into rectum, pointed end first. Retain about 15 to 20 minutes.
adults and children 12 years of age and over1 suppository in a single daily dose.
children 6 to under 12 years of age       ½ suppository in a single daily dose
children under 6 years of ageask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at 20°-25°C (68°-77°F)  

Inactive ingredient

INACTIVE INGREDIENT SECTION

hard fat

Questions?

OTC - QUESTIONS SECTION

Call 1- 866 - 844 - 2798 or visit www.Dulcolax.com

Keep carton as it contains important product information.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dulcolax
Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative
MEDICATED LAXATIVE
SUPPOSITORY
4 COMFORT SHAPED
SUPPOSITORIES
DO NOT SWALLOW

Dulcolax Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative MEDICATED LAXATIVE SUPPOSITORY 4 COMFORT SHAPED SUPPOSITORIES DO NOT SWALLOWDulcolax Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative MEDICATED LAXATIVE SUPPOSITORY 4 COMFORT SHAPED SUPPOSITORIES DO NOT SWALLOW

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN4
209601Dulcolax 10 MG Rectal SuppositoryPSN4
209601bisacodyl 10 MG Rectal Suppository [Dulcolax]SBD4
198509bisacodyl 10 MG Rectal SuppositorySCD4
209601Dulcolax 10 MG Rectal SuppositorySY4

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
41167-0210-1Dulcolax Laxative4 in 1 BLISTER PACKSUPPOSITORY44
41167-0210-1Dulcolax Laxative1 in 1 CARTONSUPPOSITORY14
41167-0210-2Dulcolax Laxative2 in 1 CARTONSUPPOSITORY24
41167-0210-2Dulcolax Laxative4 in 1 BLISTER PACKSUPPOSITORY44
41167-0210-3Dulcolax Laxative4 in 1 CARTONSUPPOSITORY44
41167-0210-3Dulcolax Laxative4 in 1 BLISTER PACKSUPPOSITORY44
41167-0210-5Dulcolax Laxative7 in 1 CARTONSUPPOSITORY74
41167-0210-5Dulcolax Laxative4 in 1 BLISTER PACKSUPPOSITORY44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0210DULCOLAX LAXATIVE (BISACODYL) SUPPOSITORY [CHATTEM, INC.]4Current NDC, Legacy NDC, 8 package rows20250207_016a4920-77a7-4ac3-8d9d-fd2f564dfee6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0210-1EA - Each41167-0210b2016e3c-efa1-4bba-b681-9b7e62ea8e6b12022-06-06
41167-0210-2EA - Each41167-0210d794afc3-6cc3-479f-9d73-d34d7132a6df12022-06-06
41167-0210-3EA - Each41167-0210a17e22f2-b481-45a1-92ea-9ff8c3dc431d12022-06-06

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
41167-021041167-0210-3, 41167-0210-5, 41167-0210-1, 41167-0210-2

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

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
Dulcolax LaxativeBISACODYLChattem, Inc.016a4920-77a7-4ac3-8d9d-fd2f564dfee62024-02-01WarningsExact identifier
ndc (package): 41167-0210-5
ndc (package): 41167-0210-1
ndc (package): 41167-0210-2
ndc (package): 41167-0210-3
ndc (product): 41167-0210
ndc11 (package): 41167021001
ndc11 (package): 41167021003
ndc11 (package): 41167021002
ndc11 (package): 41167021005
spl id: d39ca8c0-d92a-4c16-a35e-efa8acc21aa5
spl set id: 016a4920-77a7-4ac3-8d9d-fd2f564dfee6

Reported adverse events (FAERS/openFDA)#

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