Bisacodyl Enteric Coated Tablet

Manufacturer: Clinical Solutions Wholesale
Effective date: 2014-07-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:39:45

Label at a glance#

ProductBisacodyl Enteric Coated

Active ingredientBISACODYL

Label structure9 sections

Dosage and administration

-take with a glass of water adults and children 12 years 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 daily dose children under 6 years of age - ask a doctor

Contacts and useful links#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 5mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Use(s)

INDICATIONS & USAGE SECTION

-relieves occasional constipation and irregularity

-this product generally produces bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Do not use

OTC - DO NOT USE SECTION

Do not use if you cannot swallow without chewing

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

-you have a sudden change in bowel habits that lasts more than 2 weeks

-stomach pain, nausea or vomiting

OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

OTC - WHEN USING SECTION

-do not use within 1 hour after taking an antacid or milk

-do not chew or crush tablet(s)

-you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

-you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

-you need to use a laxative for more than 1 week

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professions before use.

Keep out of reach of children

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- take 1 to 3 tablets in a single daily dose

children 6 to under 12 years of age - take 1 tablet in a single daily dose

children under 6 years of age - ask a doctor

Other information

SPL UNCLASSIFIED SECTION

-store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)

-use by expiration date on package

-protect from excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.

Questions

OTC - QUESTIONS SECTION

To Report Adverse Drug Event call: (800) 616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisacodyl Enteric Coated Tabs, USP 5mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308753	bisacodyl 5 MG Delayed Release Oral Tablet	PSN	1
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	1
308753	bisacodyl 5 MG Enteric Coated 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
58118-7927-0	2020-01-31	C162847	48780-1	9d75b9d0-46f6-f424-e053-dadaa90a57ce	Bisacodyl Enteric Coated Tablet
58118-7927-3	2020-01-31	C162847	48780-1	9d75b9d0-46f6-f424-e053-dadaa90a57ce	Bisacodyl Enteric Coated Tablet
58118-7927-6	2020-01-31	C162847	48780-1	9d75b9d0-46f6-f424-e053-dadaa90a57ce	Bisacodyl Enteric Coated Tablet
58118-7927-8	2020-01-31	C162847	48780-1	9d75b9d0-46f6-f424-e053-dadaa90a57ce	Bisacodyl Enteric Coated Tablet
58118-7927-9	2020-01-31	C162847	48780-1	9d75b9d0-46f6-f424-e053-dadaa90a57ce	Bisacodyl Enteric Coated Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58118-7927-0	BisacodylEnteric Coated	1 in 1 PACKAGE	TABLET, COATED	1	1
58118-7927-3	BisacodylEnteric Coated	30 in 1 BOTTLE	TABLET, COATED	30	1
58118-7927-6	BisacodylEnteric Coated	60 in 1 BOTTLE	TABLET, COATED	60	1
58118-7927-8	BisacodylEnteric Coated	30 in 1 BLISTER PACK	TABLET, COATED	30	1
58118-7927-9	BisacodylEnteric Coated	90 in 1 BOTTLE	TABLET, COATED	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58118-7927	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1	Legacy NDC, 5 package rows	20140716_f97e277d-2fb1-4fad-845a-a1d5541dad73.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7927-17	EA - Each	0904-7927	7e7907ab-0977-40ec-a77a-d6f395a894a2	1	2013-02-13
0904-7927-60	EA - Each	0904-7927	3e50c02d-9513-47d5-bea0-f898f04891a7	1	2013-02-13
0904-7927-61	EA - Each	0904-7927	856c9c8d-f029-4cdd-b96c-8f84d822b28d	1	2013-02-13
0904-7927-80	EA - Each	0904-7927	93f3c97b-baac-4a58-b9d9-3d7f4876bfc4	1	2013-02-13

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
AMMONIUM NONOXYNOL-4 SULFATE	INACTIVE INGREDIENT	9HIA70O4J0	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
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
Polyvinyl Acetate Phthalate	INACTIVE INGREDIENT	58QVG85GW3	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	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 · 20 matching rows.

Bisacodyl Enteric Coated
Bisacodyl
ACACIA
CALCIUM SULFATE ANHYDROUS
ANHYDROUS LACTOSE
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
AMMONIUM NONOXYNOL-4 SULFATE
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TALC
TITANIUM DIOXIDE
Polyvinyl Acetate Phthalate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58118-7927	58118-7927-3, 58118-7927-6, 58118-7927-9, 58118-7927-8, 58118-7927-0
0904-7927

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
GELATIN	2G86QN327L	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
AMMONIUM NONOXYNOL-4 SULFATE	9HIA70O4J0	IACT
SHELLAC	46N107B71O	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
Polyvinyl Acetate Phthalate	58QVG85GW3	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 7 · 420 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 34 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	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	CAPSULE / ORAL		2490 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SYRUP / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	140 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, ORALLY DISINTEGRATING / ORAL		410 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 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
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE / ORAL	20 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	LOTION / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / ORAL		120 mg	Exact identifier — unii candidate 44 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, COATED PELLETS / ORAL		456 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, DELAYED RELEASE / ORAL	1.9 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, DELAYED RELEASE / ORAL		1083 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	25 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, COATED PELLETS / ORAL	29 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 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	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	PASTE / DENTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	PASTE / DENTAL		252 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	LOTION / TOPICAL	NA		Exact identifier — unii candidate 31 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
f97e277d-2fb1-4fad-845a-a1d5541dad73			f97e277d-2fb1-4fad-845a-a1d5541dad73	2014-07-01	Warnings	Exact identifier spl id: f97e277d-2fb1-4fad-845a-a1d5541dad73 spl set id: f97e277d-2fb1-4fad-845a-a1d5541dad73

Reported adverse events (FAERS/openFDA)#

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