FDA.reportPublic FDA data

Dulcolax Stimulant Laxative

Manufacturer
Chattem, Inc.
Effective date
2019-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:28:31

Label at a glance#

ProductDulcolax 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 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

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 yellow #10 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
LAXATIVE
50 TABLETS

PRINICPAL DISPLAY PANEL Dulcolax LAXATIVE 50 TABLETSPRINICPAL DISPLAY PANEL Dulcolax LAXATIVE 50 TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN2
209613Dulcolax 5 MG Delayed Release Oral TabletPSN2
209613bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]SBD2
308753bisacodyl 5 MG Delayed Release Oral TabletSCD2
308753bisacodyl 5 MG Enteric Coated Oral TabletSY2
209613Dulcolax 5 MG Delayed Release Oral TabletSY2

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
41167-0200-1Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED12
41167-0200-1Dulcolax Stimulant Laxative10 in 1 BLISTER PACKTABLET, COATED102
41167-0200-2Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED12
41167-0200-2Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED252
41167-0200-3Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED252
41167-0200-3Dulcolax Stimulant Laxative2 in 1 CARTONTABLET, COATED22
41167-0200-4Dulcolax Stimulant Laxative4 in 1 CARTONTABLET, COATED42
41167-0200-4Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED252
41167-0200-5Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED12
41167-0200-5Dulcolax Stimulant Laxative8 in 1 BLISTER PACKTABLET, COATED82
41167-0200-6Dulcolax Stimulant Laxative8 in 1 CARTONTABLET, COATED82
41167-0200-6Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED252
41167-0200-8Dulcolax Stimulant Laxative3 in 1 CARTONTABLET, COATED32
41167-0200-8Dulcolax Stimulant Laxative10 in 1 BLISTER PACKTABLET, COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0200DULCOLAX STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CHATTEM, INC.]2Current NDC, Legacy NDC, 14 package rows20200905_e0dcae0f-6dca-4700-a415-de2274e6f779.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-020041167-0200-5, 41167-0200-6, 41167-0200-8, 41167-0200-3, 41167-0200-2, 41167-0200-1, 41167-0200-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISACODYL10X0709Y6IACTIB
ACACIA5C5403N26OIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dulcolax Stimulant LaxativeBISACODYLChattem, Inc.f1e4b28a-ed74-4eff-bd10-b2bfaf7483b02025-04-08WarningsExact identifier
ndc (package): 41167-0200-5
ndc (package): 41167-0200-1
ndc (package): 41167-0200-3
ndc (package): 41167-0200-4
ndc (package): 41167-0200-6
ndc (package): 41167-0200-8
ndc (package): 41167-0200-2
ndc (product): 41167-0200
ndc11 (package): 41167020002
ndc11 (package): 41167020001
ndc11 (package): 41167020006
ndc11 (package): 41167020005
ndc11 (package): 41167020008
ndc11 (package): 41167020003
ndc11 (package): 41167020004
b68003b7-c908-431e-9165-830bbe154056e0dcae0f-6dca-4700-a415-de2274e6f7792019-01-02WarningsExact identifier
spl id: b68003b7-c908-431e-9165-830bbe154056
spl set id: e0dcae0f-6dca-4700-a415-de2274e6f779

Reported adverse events (FAERS/openFDA)#

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