FDA.reportPublic FDA data

Dulcolax Pink Stimulant Laxative

Manufacturer
Chattem, Inc.
Effective date
2025-02-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:54:26

Label at a glance#

ProductDulcolax Pink Stimulant Laxative
Active ingredientBISACODYL
Label structure10 sections

Dosage and administration

take with a glass of water adults and children 12 years of age and over 1 to 3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose 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 over1 to 3 tablets in a single daily dose
children 6 to under 12 years of age1 tablet in a single daily dose
children under 6 years of ageask a doctor

Other information

SPL UNCLASSIFIED SECTION

● contains FD&C Yellow No. 6

● do not use if individual blister unit is open or torn

● store at 20°-25°C (68°-77°F)  

● protect from excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

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) 5 mg Tablets/Stimulant Laxative
Pink
OVERNIGHT LAXATIVE
25
COMFORT COATED
TABLETS

Dulcolax Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative Pink OVERNIGHT LAXATIVE 25 COMFORT COATED TABLETSDulcolax Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative Pink OVERNIGHT LAXATIVE 25 COMFORT COATED TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN5
209613Dulcolax 5 MG Delayed Release Oral TabletPSN5
209613bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]SBD5
308753bisacodyl 5 MG Delayed Release Oral TabletSCD5
308753bisacodyl 5 MG Enteric Coated Oral TabletSY5
209613Dulcolax 5 MG Delayed Release Oral TabletSY5

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
41167-0290-5Dulcolax Pink Stimulant Laxative1 in 1 CARTONTABLET, COATED15
41167-0290-5Dulcolax Pink Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0290DULCOLAX PINK STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CHATTEM, INC.]5Current NDC, Legacy NDC, 2 package rows20250206_fb5ad666-57b3-4b95-b5de-9db5d265925e.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-029041167-0290-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISACODYL10X0709Y6IACTIB
ACACIA5C5403N26OIACT
AMMONIA5138Q19F1XIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 272LRS185U6KIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FERRIC OXIDE RED1K09F3G675IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
Polyvinyl Acetate Phthalate58QVG85GW3IACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SHELLAC46N107B71OIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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 Pink Stimulant LaxativeBISACODYLChattem, Inc.fb5ad666-57b3-4b95-b5de-9db5d265925e2025-02-05WarningsExact identifier
ndc (package): 41167-0290-5
ndc (product): 41167-0290
ndc11 (package): 41167029005
spl id: f8b7fa23-bf0f-41ef-b61d-80485494f047
spl set id: fb5ad666-57b3-4b95-b5de-9db5d265925e

Reported adverse events (FAERS/openFDA)#

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