Bisacodyl Enteric Coated Tablet

Manufacturer: P & L Development, LLC
Effective date: 2023-03-20
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 21:34:15

Label at a glance#

ProductLaxative Enteric Coated

Active ingredientBISACODYL

Label structure10 sections

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-877-753-3935

Label contents#

Full prescribing information#

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

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
a sudden change in bowel habits that lasts for 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

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	take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age	take 1 tablet in a single dose
children under 6 years of age	ask a doctor

Other information

SPL UNCLASSIFIED SECTION

store between 20-25ºC (68-77^oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, gelatin, iron oxide, iron oxide Black, iron oxide Yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, and titanium dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in DULCOLAX®*

LAXATIVE

Bisacodyl, 5 mg stimulant laxative

Gentle, Predictable, Overnight relief

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax®Lasative.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

PL Developments

200 Hicks St Westbury, NY 11590 USA

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59726-190-03	2023-03-20	C162847	48780-1	d6a99b39-d2ae-a426-e053-dadaa90af4c2	Bisacodyl Enteric Coated Tablet
59726-190-03	2022-01-28	C162847	48780-1	d6a99b39-d2ae-a426-e053-dadaa90af4c2	Bisacodyl Enteric Coated Tablet

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
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	1
CALCIUM SULFATE ANHYDROUS	INACTIVE INGREDIENT	E934B3V59H	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
Polyvinyl Acetate Phthalate	INACTIVE INGREDIENT	58QVG85GW3	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

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

Laxative Enteric Coated
Bisacodyl
DEACETYLBISACODYL
ACACIA
CALCIUM SULFATE ANHYDROUS
ANHYDROUS LACTOSE
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
ALUMINUM OXIDE
GELATIN
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
Polyvinyl Acetate Phthalate
POVIDONE
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59726-190	59726-190-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BISACODYL	10X0709Y6I	ACTIB
ACACIA	5C5403N26O	IACT
CALCIUM SULFATE ANHYDROUS	E934B3V59H	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
GELATIN	2G86QN327L	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
Polyvinyl Acetate Phthalate	58QVG85GW3	IACT
POVIDONE	FZ989GH94E	IACT
SHELLAC	46N107B71O	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML · Source PDF

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 9 · 539 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, FILM COATED / ORAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE, EXTENDED RELEASE / ORAL		288 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SYRUP / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, EXTENDED RELEASE / ORAL		1229 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SWAB / TOPICAL		5250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CONCENTRATE / ORAL	0.03 mg/1ml		Exact identifier — unii candidate 31 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRAVENOUS	20 mg		Exact identifier — unii candidate 44 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	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / ORAL	70 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER / ORAL	800 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, CHEWABLE / ORAL	0.41 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SOLUTION / ORAL		40 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL		48 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	POWDER, FOR SUSPENSION / ORAL		469 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, COATED / ORAL		560 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / PERIODONTAL	3.44 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
462d7428-ce48-41a8-ac8d-e97b6375e90b			2caa9488-eacb-4c0f-81f5-5d25397a4fb4	2023-03-20	Warnings	Exact identifier spl id: 462d7428-ce48-41a8-ac8d-e97b6375e90b spl set id: 2caa9488-eacb-4c0f-81f5-5d25397a4fb4

Reported adverse events (FAERS/openFDA)#

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