STIMULANT LAXATIVE

Manufacturer: TIME CAP LABORATORIES, INC.
Effective date: 2019-09-27
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 23:00:43

Label at a glance#

ProductSTIMULANT LAXATIVE

Active ingredientBISACODYL

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

In each tablet: Bisacodyl 5mg

INACTIVE INGREDIENT SECTION

Acadia, 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 Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

OTC - PURPOSE SECTION

Stimulant Laxative

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.

INDICATIONS & USAGE SECTION

Uses:

relieves occasional constipation and irregularity
this product generally produces a bowel movement in 6 to 12 hours

WARNINGS SECTION

Warning: Do not use if you cannot swallow without chewing.

Ask a doctor before use if you have: stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks.

When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
children 6 to under 12 years: take 1 tablet in a single daily dose
children under 6 years: ask a doctor

25 COUNT BLISTER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

100 count label 14R

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

14R 100CT LABEL

1000 CT 14R

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

14R 1000 CT LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308753	bisacodyl 5 MG Delayed Release Oral Tablet	PSN	7
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	7
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEACETYLBISACODYL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-003-00	STIMULANT LAXATIVE	100000 in 1 CARTON	TABLET, DELAYED RELEASE	100000	7
49483-003-01	STIMULANT LAXATIVE	100 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	100	7
49483-003-10	STIMULANT LAXATIVE	1000 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	1000	7
49483-003-52	STIMULANT LAXATIVE	25 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	25	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-003	STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20191004_e0a9f8d9-660b-431c-8043-6d8ec81f98e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-003-01	EA - Each	49483-003	215fe235-d140-48dc-b6c5-5c561fc7db5f	1	2012-07-24
49483-003-10	EA - Each	49483-003	12c91021-1f57-49ab-b336-737d5fc1931e	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	3
BISACODYL	ACTIVE MOIETY	10X0709Y6I	3
ACACIA	INACTIVE INGREDIENT	5C5403N26O	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	3
CALCIUM SULFATE ANHYDROUS	INACTIVE INGREDIENT	E934B3V59H	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	3
POLYVINYL ACETATE PHTHALATE	INACTIVE INGREDIENT	58QVG85GW3	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	3
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

STIMULANT LAXATIVE
BISACODYL
ACACIA
CALCIUM SULFATE ANHYDROUS
ANHYDROUS LACTOSE
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
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
SUCROSE
TALC
TITANIUM DIOXIDE
DEACETYLBISACODYL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49483-003	49483-003-10, 49483-003-01, 49483-003-52, 49483-003-00

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
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
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
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
BISACODYL	10X0709Y6I	ACTIB

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 2 · 120 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	TABLET / ORAL		1396 mg	Exact identifier — unii+route 20 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATE	POLYVINYL ACETATE PHTHALATE	58QVG85GW3	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	TABLET, EXTENDED RELEASE / ORAL		468 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	CAPSULE / ORAL	50 mg		Exact identifier — unii+route 20 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, DELAYED RELEASE / ORAL		53 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, DELAYED RELEASE / ORAL		53 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, DELAYED RELEASE / ORAL		53 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	CAPSULE / ORAL	50 mg		Exact identifier — unii+route 20 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+route+dosage form 5 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii+route+dosage form 5 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+route+dosage form 5 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, DELAYED RELEASE / ORAL		1083 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	TABLET, EXTENDED RELEASE / ORAL		468 mg	Exact identifier — unii+route 20 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 20 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	TABLET / ORAL		1396 mg	Exact identifier — unii+route 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	CAPSULE / ORAL	50 mg		Exact identifier — unii+route 20 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 20 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 20 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATE	POLYVINYL ACETATE PHTHALATE	58QVG85GW3	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, DELAYED RELEASE / ORAL		1083 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii+route+dosage form 5 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+route+dosage form 5 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	TABLET, EXTENDED RELEASE / ORAL		468 mg	Exact identifier — unii+route 20 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CALCIUM SULFATE ANHYDROUS	CALCIUM SULFATE ANHYDROUS	E934B3V59H	TABLET / ORAL		1396 mg	Exact identifier — unii+route 20 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
STIMULANT LAXATIVE	BISACODYL	TIME CAP LABORATORIES, INC.	e0a9f8d9-660b-431c-8043-6d8ec81f98e5	2019-09-27	Warnings	Exact identifier ndc (package): 49483-003-52 ndc (package): 49483-003-01 ndc (package): 49483-003-10 ndc (package): 49483-003-00 ndc (product): 49483-003 ndc11 (package): 49483000310 ndc11 (package): 49483000300 ndc11 (package): 49483000301 ndc11 (package): 49483000352 spl id: 938bf8c5-6834-6362-e053-2995a90aa7e6 spl set id: e0a9f8d9-660b-431c-8043-6d8ec81f98e5

Reported adverse events (FAERS/openFDA)#

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