Bisacodyl

Manufacturer: Pharbest Pharmaceuticals Inc.
Effective date: 2012-06-09
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:22

Label at a glance#

ProductBisacodyl

Active ingredientBISACODYL

Label structure8 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

Storage and handling

Store at 20 - 25 0 C (68-77 0 F) Protect from excessive humidity

Contacts and useful links#

PhoneLabel contact(866) 562-2756

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 5 mg

OTC - PURPOSE SECTION

Stimulant laxative

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 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	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 - 25⁰C (68-77⁰F)
Protect from excessive humidity

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (866) 562-2756

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
16103-367-08	2020-01-31	C162847	48780-1	9d75b9cf-f26f-f424-e053-dadaa90a57ce	Drug facts
16103-367-17	2020-01-31	C162847	48780-1	9d75b9cf-f26f-f424-e053-dadaa90a57ce	Drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-367-08	Bisacodyl	100 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	100		1
16103-367-17	Bisacodyl	25 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	25		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-367	BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]	1	Legacy NDC, 2 package rows	20120625_29156c82-bb48-4356-860c-ca0e9001882e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-367-08	EA - Each	16103-367	5d324daa-f273-4129-97c0-6c278fe83acc	1	2012-07-24
16103-367-17	EA - Each	16103-367	cd0f35b3-1f82-4b2f-a273-010cce32a7be	1	2012-07-24

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
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	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
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYVINYL ACETATE PHTHALATE	INACTIVE INGREDIENT	58QVG85GW3	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	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
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

Bisacodyl
ACACIA
ANHYDROUS LACTOSE
YELLOW WAX
CALCIUM SULFATE
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
FERROSOFERRIC OXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SHELLAC
POLYVINYL ACETATE PHTHALATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCROSE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16103-367	16103-367-17, 16103-367-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BISACODYL	10X0709Y6I	ACTIB
ACACIA	5C5403N26O	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
YELLOW WAX	2ZA36H0S2V	IACT
CALCIUM SULFATE	WAT0DDB505	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
FERROSOFERRIC OXIDE	XM0M87F357	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SHELLAC	46N107B71O	IACT
POLYVINYL ACETATE PHTHALATE	58QVG85GW3	IACT
POVIDONE K30	U725QWY32X	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 9 · 529 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GELATIN	GELATIN	2G86QN327L	TABLET / PERIODONTAL	3.44 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / SUBLINGUAL	1 mg		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
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		375 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	LIQUID / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 34 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET / ORAL		6795 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL		2 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 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
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	TABLET, DELAYED RELEASE / ORAL	127 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 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
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, EXTENDED RELEASE / ORAL		1229 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SYRUP / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	TABLET, COATED / ORAL	170 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, FILM COATED / ORAL	0.14 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CALCIUM SULFATE	CALCIUM SULFATE	WAT0DDB505	CAPSULE / ORAL	141.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	25 mg		Exact identifier — unii candidate 21 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
POVIDONE K30	POVIDONE K30	U725QWY32X	FILM, EXTENDED RELEASE / TRANSDERMAL		16 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, ORALLY DISINTEGRATING / ORAL		410 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / ORAL	NA		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
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, DELAYED RELEASE PELLETS / ORAL		178 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	SOLUTION / ORAL		300 mg	Exact identifier — unii candidate 40 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
a86fbc38-1f71-4abc-aade-e98304763076			29156c82-bb48-4356-860c-ca0e9001882e	2012-06-09	Warnings	Exact identifier spl id: a86fbc38-1f71-4abc-aade-e98304763076 spl set id: 29156c82-bb48-4356-860c-ca0e9001882e

Reported adverse events (FAERS/openFDA)#

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