Ferrous Gluconate 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 Gluconate

Active ingredientFERROUS GLUCONATE

Label structure6 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Dietary Supplement

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

DOSAGE & ADMINISTRATION SECTION

Serving Size 1 Tablet
Amount Per Tablet	% Daily Value
Iron (as ferrous gluconate) 38 mg	208%

Other ingredients: Colloidal Silicon Dioxide, Corn Starch, Talc, Powdered Cellulose, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide, Polyethylene Glycol, Sucrose, Calcium Carbonate, Magnesium Stearate, Copovidone, Shellac, Cocoa Butter, FD&C Blue No. 1 Aluminum Lake, Maltodextrin, Hypromellose, Riboflavin, Carnauba Wax, White Wax.

Distributed by Padagis^®
Minneapolis, MN 55427

02-23

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ferrous Gluconate Tablets, USP 324 mg

Dietary Supplement

CONTAINS: Each tablet contains 324 mg of ferrous gluconate, equivalent to 38 mg of elemental iron, providing 208% 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 three to four times daily.
Children: Consult a physician.

NET CONTENTS 100 TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198630	ferrous gluconate 324 MG (iron 38 MG) Oral Tablet	PSN	6
198630	ferrous gluconate 324 MG Oral Tablet	SCD	6
198630	ferrous gluconate 324 MG (iron 38 MG) Oral Tablet	SY	6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0574-0508-01	Ferrous Gluconate	100 in 1 BOTTLE	TABLET	100	6
0574-0508-10	Ferrous Gluconate	1000 in 1 BOTTLE	TABLET	1000	6
0574-0508-11	Ferrous Gluconate	10 in 1 BLISTER PACK	TABLET	10	6
0574-0508-11	Ferrous Gluconate	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
0574-0508	FERROUS GLUCONATE TABLET [PADAGIS US LLC]	6	4 package rows	20241101_304fdee6-0290-4717-be3d-b367bec7e411.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-0508-01	EA - Each	0574-0508	1f3c7fb5-421d-40f6-b2ed-08d071d1b96d	1	2013-02-19
0574-0508-10	EA - Each	0574-0508	ec8a1bcb-34f1-4ccd-8bf2-23ee13c8ae5a	1	2013-02-19
0574-0508-11	EA - Each	0574-0508	e61e310a-9754-4a3a-9829-c63ca492994f	1	2013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FERROUS GLUCONATE	ACTIVE INGREDIENT	U1B11I423Z	2
FERROUS CATION	ACTIVE MOIETY	GW89581OWR	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	2
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	2
RIBOFLAVIN	INACTIVE INGREDIENT	TLM2976OFR	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	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 · 20 matching rows.

Ferrous Gluconate
FERROUS CATION
SILICON DIOXIDE
STARCH, CORN
TALC
POWDERED CELLULOSE
STEARIC ACID
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
SUCROSE
CALCIUM CARBONATE
MAGNESIUM STEARATE
COPOVIDONE K25-31
SHELLAC
COCOA BUTTER
FD&C BLUE NO. 1
MALTODEXTRIN
RIBOFLAVIN
CARNAUBA WAX
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0574-0508	0574-0508-01, 0574-0508-11, 0574-0508-10

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
FERROUS GLUCONATE	U1B11I423Z	ACTIM
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SUCROSE	C151H8M554	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
COPOVIDONE K25-31	D9C330MD8B	IACT
SHELLAC	46N107B71O	IACT
COCOA BUTTER	512OYT1CRR	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
RIBOFLAVIN	TLM2976OFR	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 7 · 399 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	FILM, SOLUBLE / ORAL		14 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, COATED PELLETS / ORAL	29 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL		1582 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE / ORAL	349.9 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 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
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, EXTENDED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 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
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / INTRAVENOUS	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 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
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 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
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	CAPSULE, COATED PELLETS / ORAL		88 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	TABLET, CHEWABLE / ORAL		5 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

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