FERROUS SULFATE TABLETS USP 325 MG

Manufacturer: SPIRIT PHARMACEUTICALS,LLC
Effective date: 2010-12-09
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:26:44

Label at a glance#

ProductFERROUS SULFATE

Active ingredientFERROUS SULFATE, DRIED

Label structure8 sections

Storage and handling

* Store at room temperature

Contacts and useful links#

PhoneLabel contact215 943 4000

PhoneLabel contact215 943 4039

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each Caplet)

OTC - ACTIVE INGREDIENT SECTION

Dried Ferrous Sulfate 325 mg

Purpose

OTC - PURPOSE SECTION

INDICATIONS & USAGE SECTION

Iron Supplement Therapy

Ferrous Sulphate is an iron supplement for iron deficiency and iron deficiency anemia when the need for such therapy has been determined by a physician.

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within tow hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing products may occasionally cause constipation or diarrhea.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If are pregnant or nursing a baby, seek the advise of a health professional before using this products.

OTC - KEEP OUT OF REACH OF CHILDREN 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.

Direction

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over : take 1 tablet daily or as directed by a doctor
Children under 12 years : consult a physician..

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Starch USP, Calcium Carbonate USP, Guar Gum , Magnesium Stearate USP, Talc USP, Colloidal Silicon Dioxide USP, , Carnuba Wax

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FERROUS SULFATE TABLETS USP 325 MG

Each film coated tablet contains:
Ferrous Sulfate tablet USP 325 mg
(Equivalent to 65 mg of elimental IRON)

LOT NO	:	QUANTITY	: 15000
DRUM NO	:	NDC NO	: 68210-1520-1
MFG. DATE	:	EXP. DATE	:

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPRATURE OF 59° – 86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE F.D & C.ACT AND REGULATIONS THEREUNDER

MANUFACTURED BY:
LIC NO : GUJ/DRUGS/G/505
MARKSANS PHARMA LTD
UDYOGNAGAR,NAVSARI-396445
INDIA

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS , PA 19030
PH.# 215 943 4000, FAX.#215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

Principal Display Panel - Shipping Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310325	ferrous sulfate 325 MG (iron 65 MG) Oral Tablet	PSN	1
310325	ferrous sulfate 325 MG Oral Tablet	SCD	1
310325	ferrous sulfate 324 MG (iron 65 MG) Oral Tablet	SY	1
310325	ferrous sulfate 325 MG (iron 65 MG) Oral Tablet	SY	1
310325	FESO4 325 MG Oral Tablet	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
910c1bd7-67d1-44c7-ad4f-9445f827edcc	Product name	1	20230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68210-1520-1	2019-10-29	C162847	48780-1	960f7f55-c326-8e05-e053-dbdaa90a074a	FERROUS SULFATE TABLETS USP 325 MG
68210-1520-2	2019-10-29	C162847	48780-1	960f7f55-c326-8e05-e053-dbdaa90a074a	FERROUS SULFATE TABLETS USP 325 MG
68210-1520-3	2019-10-29	C162847	48780-1	960f7f55-c326-8e05-e053-dbdaa90a074a	FERROUS SULFATE TABLETS USP 325 MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68210-1520-1	FERROUS SULFATE	15000 in 1 BAG	TABLET, FILM COATED	15000	1
68210-1520-1	FERROUS SULFATE	1 in 1 DRUM	TABLET, FILM COATED	1	1
68210-1520-2	FERROUS SULFATE	10000 in 1 BAG	TABLET, FILM COATED	10000	1
68210-1520-2	FERROUS SULFATE	1 in 1 DRUM	TABLET, FILM COATED	1	1
68210-1520-3	FERROUS SULFATE	1 in 1 DRUM	TABLET, FILM COATED	1	1
68210-1520-3	FERROUS SULFATE	1000 in 1 BAG	TABLET, FILM COATED	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-1520	FERROUS SULFATE (FERROUS SULFATE, DRIED) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS,LLC]	1	Legacy NDC, 6 package rows	20101222_292ab31a-4857-4960-995d-e80f09106e28.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FERROUS SULFATE, DRIED	ACTIVE INGREDIENT	RIB00980VW	1
IRON	ACTIVE MOIETY	E1UOL152H7	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

FERROUS SULFATE
FERROUS SULFATE, DRIED
IRON
CALCIUM CARBONATE
GUAR GUM
MAGNESIUM STEARATE
TALC
SILICON DIOXIDE
CARNAUBA WAX
HYPROMELLOSES
TITANIUM DIOXIDE
FD&C YELLOW NO. 5
FD&C BLUE NO. 2
ALUMINUM OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68210-1520	68210-1520-1, 68210-1520-2, 68210-1520-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FERROUS SULFATE, DRIED	RIB00980VW	ACTIB
CALCIUM CARBONATE	H0G9379FGK	IACT
GUAR GUM	E89I1637KE	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
TALC	7SEV7J4R1U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
ALUMINUM OXIDE	LMI26O6933	IACT

Source Document#

Source XML · Source PDF

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 5 · 266 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, EXTENDED RELEASE / ORAL	2.03 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	LOTION / TOPICAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 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	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, DELAYED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE / ORAL	349.9 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SYRUP / ORAL		250 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE, EXTENDED RELEASE / ORAL	0.26 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	SOAP / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / ORAL	1 mg/1ml		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SYRUP / ORAL	0.1 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 11 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
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 35 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
a71178c0-3156-4c4e-a189-357939a27e27			292ab31a-4857-4960-995d-e80f09106e28	2010-12-09	Warnings	Exact identifier spl id: a71178c0-3156-4c4e-a189-357939a27e27 spl set id: 292ab31a-4857-4960-995d-e80f09106e28

Reported adverse events (FAERS/openFDA)#

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