FDA.reportPublic FDA data

Ferrous Sulfate Tablets 325 mg Iron Supplement

Manufacturer
Rising Pharma Holdings, Inc. | Nucrogene Inc
Effective date
2025-11-13
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:52:14

Label at a glance#

ProductFerrous Sulfate
Active ingredientFERROUS SULFATE
Label structure5 sections

Dosage and administration

Adults and children over 12 years of age: 1 tablet daily preferably with a meal or as directed by a doctor. Children under 12 years of age:  Consult a doctor.  Do not exceed recommended dosage.

Label contents#

Full prescribing information#

Supplement Facts

STATEMENT OF IDENTITY SECTION

Serving size: 1 Tablet

Servings Per Container: 100 and 1,000

Amount Per Serving   % Daily Value
 Iron (as dried ferrous sulfate) 65 mg361%

Other Ingredients: Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Red No. 40, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin.

Formula: Each tablet contains 202 mg of dried ferrous sulfate USP (65 mg of elemental iron), equivalent to 325 mg of ferrous sulfate USP.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age: 1 tablet daily preferably with a meal or as directed by a doctor. Children under 12 years of age: Consult a doctor. Do not exceed recommended dosage.

Caution:

WARNINGS SECTION

Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within two hours of each other. Iron containing products may cause constipation and diarrhea. If you are pregnant, nursing or taking any medications, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur. 

Store at room temperature. Keep tightly closed in a cool dry place.

Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

SAFE HANDLING WARNING SECTION

Questions or comments? call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ferrous-sulfate-100ctferrous-sulfate-100ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletPSN1
310325ferrous sulfate 325 MG Oral TabletSCD1
310325ferrous sulfate 324 MG (iron 65 MG) Oral TabletSY1
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletSY1
310325FESO4 325 MG Oral TabletSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357237364017GTIN-13: 0357237364017
EAN-13: 0357237364017
GTIN-12: 357237364017
UPC-A: 357237364017
GTIN storage (14 digits): 00357237364017		ferrous-sulfate-100ct.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-364-01Ferrous Sulfate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
57237-364-10Ferrous Sulfate1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-36457237-364-01, 57237-364-10

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
NameUNIIKind
FERROUS SULFATE39R4TAN1VTACTIM
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FERRUM SULPHURICUMFERROUS SULFATEBoiron3a749d62-0e20-0c15-e063-6394a90ac1a82025-07-21Name fallback
generic name: FERROUS SULFATE
FERROUS SULFATEFERROUS SULFATERichmond Pharmaceuticals, Inc.58dd4f30-980b-44bc-9f8e-8d4626854b912024-12-26WarningsName fallback
brand name: FERROUS SULFATE
generic name: FERROUS SULFATE
Ferrous SulfateFERROUS SULFATERichmond Pharmaceuticals Inc.5514d582-19b5-4f1e-b794-f790afb8211c2024-12-26Boxed warning, WarningsName fallback
brand name: Ferrous Sulfate
generic name: FERROUS SULFATE
Ferrum sulphuricumFERROUS SULFATEBoiron7a4087d8-d054-bbdc-e053-2991aa0ae8cf2023-11-13Name fallback
generic name: FERROUS SULFATE

Reported adverse events (FAERS/openFDA)#

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