FDA.reportPublic FDA data

Dulcolax Simulant Laxative

Manufacturer
Chattem, Inc.
Effective date
2025-04-01
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:00:07

Label at a glance#

ProductDulcolax Simulant Laxative
Active ingredientBISACODYL
Label structure10 sections

Dosage and administration

● Take with a glass of water adults and children 12 years of age and over start with 1 tablet/day. If needed, increase to 2 or 3 tablets a day in a single daily dose. children 6 to under 12 years of age 1 tablet per day children under 6 years of age ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Dulcolax®

Stimulant Laxative Tablets

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl (USP) 5 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 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

● if you cannot swallow without chewing

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 and cramps

● do not chew or crush tablet(s)

● do not use within 1 hour after taking an antacid or milk

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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

● Take with a glass of water
adults and children 12 years of age and overstart with 1 tablet/day. If needed, increase to 2 or 3 tablets a day in a single daily dose.
children 6 to under 12 years of age1 tablet per day
children under 6 years of ageask a doctor

Other information

SPL UNCLASSIFIED SECTION

● store at 20°-25°C (68°-77°F)

● protect from excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerol monostearate, hypromellose, iron oxides, lactose, macrogol 6000, magnesium stearate, methacrylic acid - ethyl acrylate copolymer, polysorbate 80, pregelatinized maize starch, stearic acid, triethyl citrate, water

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

OVERNIGHT RELIEF
Dulcolax
LAXATIVE
25 comfort coated Tablets

PRINCIPAL DISPLAY PANEL OVERNIGHT RELIEF Dulcolax LAXATIVE 25 comfort coated TabletsPRINCIPAL DISPLAY PANEL OVERNIGHT RELIEF Dulcolax LAXATIVE 25 comfort coated Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN8
209613Dulcolax 5 MG Delayed Release Oral TabletPSN8
209613bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]SBD8
308753bisacodyl 5 MG Delayed Release Oral TabletSCD8
308753bisacodyl 5 MG Enteric Coated Oral TabletSY8
209613Dulcolax 5 MG Delayed Release Oral TabletSY8

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
41167-0101-0Dulcolax Simulant Laxative8 in 1 BLISTER PACKTABLET, FILM COATED88
41167-0101-0Dulcolax Simulant Laxative1 in 1 CARTONTABLET, FILM COATED18
41167-0101-1Dulcolax Simulant Laxative10 in 1 BLISTER PACKTABLET, FILM COATED108
41167-0101-1Dulcolax Simulant Laxative1 in 1 CARTONTABLET, FILM COATED18
41167-0101-2Dulcolax Simulant Laxative1 in 1 CARTONTABLET, FILM COATED18
41167-0101-2Dulcolax Simulant Laxative25 in 1 BLISTER PACKTABLET, FILM COATED258
41167-0101-3Dulcolax Simulant Laxative25 in 1 BLISTER PACKTABLET, FILM COATED258
41167-0101-3Dulcolax Simulant Laxative2 in 1 CARTONTABLET, FILM COATED28
41167-0101-4Dulcolax Simulant Laxative25 in 1 BLISTER PACKTABLET, FILM COATED258
41167-0101-4Dulcolax Simulant Laxative4 in 1 CARTONTABLET, FILM COATED48
41167-0101-5Dulcolax Simulant Laxative8 in 1 CARTONTABLET, FILM COATED88
41167-0101-5Dulcolax Simulant Laxative25 in 1 BLISTER PACKTABLET, FILM COATED258
41167-0101-6Dulcolax Simulant Laxative3 in 1 CARTONTABLET, FILM COATED38
41167-0101-6Dulcolax Simulant Laxative10 in 1 BLISTER PACKTABLET, FILM COATED108
41167-0101-7Dulcolax Simulant Laxative1 in 1 CARTONTABLET, FILM COATED18
41167-0101-7Dulcolax Simulant Laxative6 in 1 BLISTER PACKTABLET, FILM COATED68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0101DULCOLAX SIMULANT LAXATIVE (BISACODYL) TABLET, FILM COATED [CHATTEM, INC.]8Current NDC, Legacy NDC, 16 package rows20250501_d285651b-7ccc-4ae5-a862-7a38dffefa28.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-010141167-0101-0, 41167-0101-1, 41167-0101-2, 41167-0101-3, 41167-0101-4, 41167-0101-5, 41167-0101-6, 41167-0101-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISACODYL10X0709Y6IACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYPROMELLOSES3NXW29V3WOIACT
FERRIC OXIDE RED1K09F3G675IACT
LACTOSEJ2B2A4N98GIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
MAGNESIUM STEARATE70097M6I30IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERNX76LV5T8JIACT
POLYSORBATE 806OZP39ZG8HIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
WATER059QF0KO0RIACT

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 Simulant LaxativeBISACODYLChattem, Inc.d285651b-7ccc-4ae5-a862-7a38dffefa282025-04-01WarningsExact identifier
ndc (package): 41167-0101-6
ndc (package): 41167-0101-4
ndc (package): 41167-0101-5
ndc (package): 41167-0101-1
ndc (package): 41167-0101-3
ndc (package): 41167-0101-0
ndc (package): 41167-0101-2
ndc (package): 41167-0101-7
ndc (product): 41167-0101
ndc11 (package): 41167010100
ndc11 (package): 41167010105
ndc11 (package): 41167010107
ndc11 (package): 41167010103
ndc11 (package): 41167010106
ndc11 (package): 41167010101
ndc11 (package): 41167010104
ndc11 (package): 41167010102
spl id: 4c5644fe-e922-4f9d-b80a-c18ac5454309
spl set id: d285651b-7ccc-4ae5-a862-7a38dffefa28

Reported adverse events (FAERS/openFDA)#

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