FERROUS SULFATE ENTERIC-COATED TABLETS

Manufacturer: Padagis US LLC
Effective date: 2024-10-30
Label type: DIETARY SUPPLEMENT
Version: 6
Source: full-release
Hydrated at: 2026-06-01 02:51:15

Label at a glance#

ProductFerrous Sulfate

Active ingredientFERROUS SULFATE

Label structure8 sections

Dosage and administration

Do not crush or chew tablets. Adult Serving Size: 1 tablet two to three times daily. Children: Consult a physician.

Contacts and useful links#

Websitewww.padagis.com

www.padagis.com

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Dietary Supplement

CONTAINS:

DOSAGE & ADMINISTRATION SECTION

Each tablet contains 324 mg of ferrous sulfate, equivalent to 65 mg of elemental iron, providing 362% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

DIRECTIONS FOR USE:

DOSAGE & ADMINISTRATION SECTION

Do not crush or chew tablets. Adult Serving Size: 1 tablet two to three times daily. Children: Consult a physician.

WARNINGS SECTION

WARNING:

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

WARNINGS:

WARNINGS SECTION

Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product. U.S. Consumer Product Safety Commission requires that iron-containing medicines and vitamins with iron be packaged in child-resistant closures. Parents should always properly resecure safety closures.

STORAGE:

SAFE HANDLING WARNING SECTION

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Supplement Facts

STATEMENT OF IDENTITY SECTION

Serving Size 1 Tablet
Amount Per Tablet	% Daily Value
Iron (as ferrous sulfate)	65 mg	362%

Other ingredients: Corn Starch, Calcium Stearate, Powdered Cellulose, Lactose, Talc, Copovidone, Polyethylene Glycol, Maltodextrin, Sucrose, Povidone, Calcium Carbonate, Titanium Dioxide, Magnesium Stearate, Shellac, Cocoa Butter, FD&C Red No. 40 Aluminum Lake, Sodium Starch Glycolate A, Sodium Lauryl Sulfate, Colloidal Silicon Dioxide, Methacrylic Acid Copolymer Type C, Sodium Hydroxide, Simethicone Emulsion, Diethyl Phthalate, Hypromellose, Carnauba Wax, White Wax.

Manufactured for Padagis^®
Minneapolis, MN 55427
www.padagis.com

02-23

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ferrous Sulfate Enteric-Coated Tablets

324 mg

Dietary Supplement

CONTAINS: Each tablet contains 324 mg of ferrous sulfate, equivalent to 65 mg of elemental iron, providing 362% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

DIRECTIONS FOR USE: Do not crush or chew tablets.
Adult Serving Size: 1 tablet two to three times daily.
Children: Consult a physician.

NET CONTENTS 100 TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1860100	ferrous sulfate 324 MG (iron 65 MG) Delayed Release Oral Tablet	PSN	6
1860100	ferrous sulfate 324 MG Delayed Release Oral Tablet	SCD	6
1860100	ferrous sulfate 324 MG (iron 65 MG) Delayed Release Oral Tablet	SY	6
1860100	FESO4 324 MG Delayed Release Oral Tablet	SY	6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0574-0608-01	Ferrous Sulfate	100 in 1 BOTTLE	TABLET	100	6
0574-0608-10	Ferrous Sulfate	1000 in 1 BOTTLE	TABLET	1000	6
0574-0608-11	Ferrous Sulfate	10 in 1 BLISTER PACK	TABLET	10	6
0574-0608-11	Ferrous Sulfate	10 in 1 CARTON	TABLET	10	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-0608	FERROUS SULFATE TABLET [PADAGIS US LLC]	6	4 package rows	20241101_662cc31c-e977-4f7b-b9e4-3d932982103c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-0608-01	EA - Each	0574-0608	9f1a99dd-2e05-454f-be2a-4a3d63ae9c5c	1	2013-02-19
0574-0608-10	EA - Each	0574-0608	bb3df45b-bbb5-460c-97d8-05f61afedc08	1	2013-02-19
0574-0608-11	EA - Each	0574-0608	41125e63-93e1-46b1-a8ae-8e42b8e61d0d	1	2013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FERROUS SULFATE	ACTIVE INGREDIENT	39R4TAN1VT	2
FERROUS CATION	ACTIVE MOIETY	GW89581OWR	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	2
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	2
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	2
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	2

Products#

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

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

Ferrous Sulfate
FERROUS CATION
STARCH, CORN
CALCIUM STEARATE
POWDERED CELLULOSE
LACTOSE, UNSPECIFIED FORM
TALC
COPOVIDONE K25-31
POLYETHYLENE GLYCOL, UNSPECIFIED
MALTODEXTRIN
SUCROSE
POVIDONE, UNSPECIFIED
CALCIUM CARBONATE
TITANIUM DIOXIDE
MAGNESIUM STEARATE
SHELLAC
COCOA BUTTER
FD&C RED NO. 40
SODIUM LAURYL SULFATE
SILICON DIOXIDE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
SODIUM HYDROXIDE
DIETHYL PHTHALATE
HYPROMELLOSE, UNSPECIFIED
CARNAUBA WAX
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0574-0608	0574-0608-01, 0574-0608-11, 0574-0608-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FERROUS SULFATE	39R4TAN1VT	ACTIM
STARCH, CORN	O8232NY3SJ	IACT
CALCIUM STEARATE	776XM7047L	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT
TALC	7SEV7J4R1U	IACT
COPOVIDONE K25-31	D9C330MD8B	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
SUCROSE	C151H8M554	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SHELLAC	46N107B71O	IACT
COCOA BUTTER	512OYT1CRR	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER	NX76LV5T8J	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
DIETHYL PHTHALATE	UF064M00AF	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
WHITE WAX	7G1J5DA97F	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 12 · 706 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SHELLAC	SHELLAC	46N107B71O	TABLET / ORAL		112 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCONJUNCTIVAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CALCIUM STEARATE	CALCIUM STEARATE	776XM7047L	TABLET, ORALLY DISINTEGRATING / ORAL		112 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, EXTENDED RELEASE / ORAL	75.01 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / BUCCAL	4.5 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, DELAYED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 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
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / VAGINAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	TABLET, FILM COATED / ORAL		5917 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	TABLET, EXTENDED RELEASE / ORAL		403 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SPRAY / TOPICAL		7 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, COATED PELLETS / ORAL	29 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVENOUS		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FERRUM SULPHURICUM	FERROUS SULFATE	Boiron	3a749d62-0e20-0c15-e063-6394a90ac1a8	2025-07-21		Name fallback generic name: FERROUS SULFATE
FERROUS SULFATE	FERROUS SULFATE	Richmond Pharmaceuticals, Inc.	58dd4f30-980b-44bc-9f8e-8d4626854b91	2024-12-26	Warnings	Name fallback brand name: FERROUS SULFATE generic name: FERROUS SULFATE
Ferrous Sulfate	FERROUS SULFATE	Richmond Pharmaceuticals Inc.	5514d582-19b5-4f1e-b794-f790afb8211c	2024-12-26	Boxed warning, Warnings	Name fallback brand name: Ferrous Sulfate generic name: FERROUS SULFATE
Ferrum sulphuricum	FERROUS SULFATE	Boiron	7a4087d8-d054-bbdc-e053-2991aa0ae8cf	2023-11-13		Name fallback generic name: FERROUS SULFATE

Reported adverse events (FAERS/openFDA)#

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