Dulcolax ® Tablets

Manufacturer: Physicians Total Care, Inc.
Effective date: 2011-11-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:30:29

Label at a glance#

ProductDulcolax

Active ingredientbisacodyl

Label structure7 sections

Indications and uses

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

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 2 years of age ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)	Purpose
Bisacodyl USP 5 mg ....................................	Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

OTC - PURPOSE 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)
it may cause stomach discomfort, faintness and cramps
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 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 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 2 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dulcolax (bisacodyl USP) laxative tablets

5 mg

NDC 54868-0016-0

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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
54868-0016-0	2019-09-24	C162847	48780-1	9350213a-49ca-c013-e053-90daa90a1393	Dulcolax ® Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54868-0016-0	Dulcolax	1 in 1 CARTON	TABLET, COATED	1		1
54868-0016-0	Dulcolax	10 in 1 BLISTER PACK	TABLET, COATED	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-0016	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1	2 package rows	20120103_2913bcab-0cef-4796-9726-5906f4ec63f8.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
dibutyl phthalate	INACTIVE INGREDIENT	2286E5R2KE	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	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 glycol	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 · 24 matching rows.

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54868-0016	54868-0016-0
0597-0012

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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 glycol	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

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 11 · 656 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sorbitan monooleate	SORBITAN MONOOLEATE	06XEA2VD56	CAPSULE / ORAL		288 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
acacia	ACACIA	5C5403N26O	TABLET, EXTENDED RELEASE / ORAL	34.4 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
white wax	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL		48 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / ORAL		120 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
acacia	ACACIA	5C5403N26O	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 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
sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
sorbitan monooleate	SORBITAN MONOOLEATE	06XEA2VD56	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
docusate sodium	DOCUSATE SODIUM	F05Q2T2JA0	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
kaolin	KAOLIN	24H4NWX5CO	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
kaolin	KAOLIN	24H4NWX5CO	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
gelatin	GELATIN	2G86QN327L	PASTILLE / ORAL	143 mg		Exact identifier — unii candidate 44 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
6dee501e-2e58-4ff2-901b-8f8693c776b7			2913bcab-0cef-4796-9726-5906f4ec63f8	2011-11-04	Warnings	Exact identifier spl id: 6dee501e-2e58-4ff2-901b-8f8693c776b7 spl set id: 2913bcab-0cef-4796-9726-5906f4ec63f8

Reported adverse events (FAERS/openFDA)#

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