Dulcolax

Manufacturer: Mechanical Servants, Inc. | Boehringer Ingelheim Promeco S.A. de C.V.
Effective date: 2012-01-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:31:06

Label at a glance#

ProductDulcolax

Active ingredientbisacodyl

Label structure11 sections

Dosage and administration

take with a glass of water adults and children 12 years 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

Storage and handling

store at 20-25°C (68-77°F) protect from excessive humidity

Contacts and useful links#

PhoneLabel contact1-888-285-9159

Websitewww.dulcolax.com

www.DULCOLAX.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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 temporary relief of occasional constipation and irregularity
this product generally produces bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you cannot swallow without chewing

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

When using this product

OTC - WHEN USING SECTION

do not chew or crush tablet(s)
do not use within 1 hour after taking an antacid or milk
it may cause stomach discomfort, faintness and cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or no 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 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

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)
protect from excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake

Questions

OTC - QUESTIONS SECTION

1-888-285-9159 (English/Spanish)

Or visit www.DULCOLAX.com

SPL UNCLASSIFIED SECTION

Repackaged and distributed by Convenience Valet^® Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 5 mg Pouch Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CONVENIENCE
CV
VALET^®

DRINKING CUP
INCLUDED

Dulcolax^®
LAXATIVE
(bisacodyl USP 5 mg)
C6A

3 TABLETS

PRINCIPAL DISPLAY PANEL - 5 mg Pouch Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308753	bisacodyl 5 MG Delayed Release Oral Tablet	PSN	1
209613	Dulcolax 5 MG Delayed Release Oral Tablet	PSN	1
209613	bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]	SBD	1
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	1
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	1
209613	Dulcolax 5 MG Delayed Release Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BISACODYL Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20101101

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
29485-6741-3	2019-11-13	C162847	48780-1	97449f38-b900-f6ea-e053-dbdaa90aa703	Dulcolax ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29485-6741-3	Dulcolax	1 in 1 PACKAGE	TABLET, COATED	1		1
29485-6741-3	Dulcolax	3 in 1 POUCH	TABLET, COATED	3		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-6741	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1	Legacy NDC, 2 package rows	20120308_eac116c1-d109-4c01-8cd4-ba27ddd2ce40.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	1
bisacodyl	ACTIVE MOIETY	10X0709Y6I	1
acacia	INACTIVE INGREDIENT	5C5403N26O	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	1
cellacefate	INACTIVE INGREDIENT	F2O5O2OI9F	1
diacetylated monoglycerides	INACTIVE INGREDIENT	5Z17386USF	1
dibutyl phthalate	INACTIVE INGREDIENT	2286E5R2KE	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
kaolin	INACTIVE INGREDIENT	24H4NWX5CO	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
shellac	INACTIVE INGREDIENT	46N107B71O	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
sorbitan monooleate	INACTIVE INGREDIENT	06XEA2VD56	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	1
sucrose	INACTIVE INGREDIENT	C151H8M554	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
white wax	INACTIVE INGREDIENT	7G1J5DA97F	1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

Dulcolax
bisacodyl
acacia
carnauba wax
cellacefate
starch, corn
dibutyl phthalate
docusate sodium
gelatin
glycerin
kaolin
lactose
magnesium stearate
methylparaben
shellac
polyethylene glycols
povidone
propylparaben
sodium benzoate
sorbitan monooleate
sucrose
talc
titanium dioxide
white wax
diacetylated monoglycerides
FERRIC OXIDE RED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
29485-6741	29485-6741-3
0597-0012

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
bisacodyl	10X0709Y6I	ACTIB
acacia	5C5403N26O	IACT
carnauba wax	R12CBM0EIZ	IACT
cellacefate	F2O5O2OI9F	IACT
starch, corn	O8232NY3SJ	IACT
dibutyl phthalate	2286E5R2KE	IACT
docusate sodium	F05Q2T2JA0	IACT
gelatin	2G86QN327L	IACT
glycerin	PDC6A3C0OX	IACT
kaolin	24H4NWX5CO	IACT
lactose	J2B2A4N98G	IACT
magnesium stearate	70097M6I30	IACT
methylparaben	A2I8C7HI9T	IACT
shellac	46N107B71O	IACT
polyethylene glycols	3WJQ0SDW1A	IACT
povidone	FZ989GH94E	IACT
propylparaben	Z8IX2SC1OH	IACT
sodium benzoate	OJ245FE5EU	IACT
sorbitan monooleate	06XEA2VD56	IACT
sucrose	C151H8M554	IACT
talc	7SEV7J4R1U	IACT
titanium dioxide	15FIX9V2JP	IACT
white wax	7G1J5DA97F	IACT
diacetylated monoglycerides	5Z17386USF	IACT
FERRIC OXIDE RED	1K09F3G675	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 12 · 685 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	INJECTION / INTRAMUSCULAR	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
acacia	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	CAPSULE, COATED PELLETS / ORAL	29 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitan monooleate	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	INJECTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, EXTENDED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET / BUCCAL	15 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
sorbitan monooleate	SORBITAN MONOOLEATE	06XEA2VD56	CREAM / TOPICAL		11000 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
diacetylated monoglycerides	DIACETYLATED MONOGLYCERIDES	5Z17386USF	SOLUTION / ORAL		1728 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, FILM COATED / ORAL		57 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
diacetylated monoglycerides	DIACETYLATED MONOGLYCERIDES	5Z17386USF	CAPSULE, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CREAM / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	CAPSULE, COATED PELLETS / ORAL	65 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
docusate sodium	DOCUSATE SODIUM	F05Q2T2JA0	SUSPENSION / ORAL		48 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
white wax	WHITE WAX	7G1J5DA97F	CREAM, AUGMENTED / TOPICAL	10 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
white wax	WHITE WAX	7G1J5DA97F	AEROSOL, FOAM / TOPICAL	2 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	SOLUTION / ORAL	34.8 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
92448d56-6df2-40f1-9d69-2f42999ae3c0			eac116c1-d109-4c01-8cd4-ba27ddd2ce40	2012-01-06	Warnings	Exact identifier spl id: 92448d56-6df2-40f1-9d69-2f42999ae3c0 spl set id: eac116c1-d109-4c01-8cd4-ba27ddd2ce40

Reported adverse events (FAERS/openFDA)#

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