Enteric Coated Stimulant Laxative

Manufacturer: Bryant Ranch Prepack
Effective date: 2014-07-28
Label type: HUMAN OTC DRUG LABEL
Version: 1001
Source: legacy-cache
Hydrated at: 2026-08-02 01:35:22

Label at a glance#

ProductEnteric Coated Stimulant Laxative

Active ingredientBISACODYL

Label structure16 sections

Storage and handling

Other information store at 20°-25°C (68°-77°F)

Contacts and useful links#

PhoneLabel contact1-800-645-2158

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Bisacodyl 5 mg

OTC - PURPOSE SECTION

Purpose

Laxative

INDICATIONS & USAGE SECTION

Uses

relieves occasional constipation
generally produces bowel movement in 6-12 hours

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

for longer than one week
when abdominal pain, nausea or vomiting are present
in children under 6 years of age
in persons who cannot swallow without chewing

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

OTC - WHEN USING SECTION

When using this product

do not take dose within one hour of taking an antacid or milk
you may experience abdominal discomfort, faintness and cramps

OTC - STOP USE SECTION

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use of this product

These may indicate a serious condition.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

DO NOT CHEW TABLETS

adults and children 12 years and over: 1-3 tablets once daily

children 6 to 11 years: 1 tablet once daily

children under 6 years: ask a doctor

STORAGE AND HANDLING SECTION

Other information

store at 20°-25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients 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, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisacodyl 5mg Tablet

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-3049-1	2021-08-17	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-2	2021-08-17	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-3	2021-08-17	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-4	2021-08-17	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-5	2021-08-17	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-6	2021-08-17	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-7	2021-08-17	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-8	2021-08-17	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-1	2019-11-27	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-2	2019-11-27	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-3	2019-11-27	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-4	2019-11-27	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-5	2019-11-27	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-6	2019-11-27	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-7	2019-11-27	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS
63629-3049-8	2019-11-27	C162847	48780-1	9855e2a2-4de5-60a7-e053-dbdaa90a05bd	DRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3049-1	EA - Each	63629-3049	f91d6c82-5159-4c45-b3d9-b3ba16daf71b	1	2013-03-03
63629-3049-2	EA - Each	63629-3049	7fb1443f-b1bb-49c6-9f5e-476e4af9251d	1	2013-03-03
63629-3049-3	EA - Each	63629-3049	8a8fb6f9-312b-458c-ad82-a8960961e485	1	2013-03-03
63629-3049-4	EA - Each	63629-3049	47c9a236-7a55-4ef4-83d0-73a1dc3c2d79	1	2013-03-03
63629-3049-5	EA - Each	63629-3049	1479bfbe-79ed-4d64-8951-97be7e27f658	1	2013-03-03
63629-3049-6	EA - Each	63629-3049	2a7a29d8-6fe1-4fc5-9a41-c718f50c44a6	1	2015-10-02
0536-3381-01	EA - Each	0536-3381	339543bc-2ebf-4d02-9bb3-f9f51845c866	1	2012-07-24
0536-3381-10	EA - Each	0536-3381	d63a3c8e-e182-4118-a7bf-efa95465b548	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	1001
BISACODYL	ACTIVE MOIETY	10X0709Y6I	1001
ACACIA	INACTIVE INGREDIENT	5C5403N26O	1001
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	1001
CALCIUM SULFATE ANHYDROUS	INACTIVE INGREDIENT	E934B3V59H	1001
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1001
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1001
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1001
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1001
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1001
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1001
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1001
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1001
POLYVINYL ACETATE PHTHALATE	INACTIVE INGREDIENT	58QVG85GW3	1001
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	1001
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1001
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1001
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1001
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1001
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1001
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1001

Products#

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

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

Enteric Coated 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
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYVINYL ACETATE PHTHALATE
POVIDONES
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCROSE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63629-3049	63629-3049-1, 63629-3049-2, 63629-3049-3, 63629-3049-4, 63629-3049-5, 63629-3049-6, 63629-3049-7, 63629-3049-8
0536-3381

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
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
POVIDONES	FZ989GH94E	IACT
SHELLAC	46N107B71O	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 10 · 585 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 36 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	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 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	ELIXIR / ORAL	5.4 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	PASTE / DENTAL		252 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
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
ACACIA	ACACIA	5C5403N26O	TABLET / SUBLINGUAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / TOPICAL		6300 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	GRANULE, FOR SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / SUBLINGUAL		19 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, EXTENDED RELEASE / ORAL	4.59 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SOLUTION / ORAL	34.8 mg		Exact identifier — unii candidate 44 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 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
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / BUCCAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / BUCCAL		1 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / NASAL	50 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 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
54eff9d1-d63b-48cc-98ea-ea55c1de4975			5f03362d-792e-433c-9375-0fde1cbefa67	2021-08-17	Warnings	Exact identifier spl set id: 5f03362d-792e-433c-9375-0fde1cbefa67

Reported adverse events (FAERS/openFDA)#

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