FDA.reportPublic FDA data

FERROUS SULFATE ENTERIC-COATED TABLETS

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2025-12-03
Label type
DIETARY SUPPLEMENT
Version
10
Source
full-release
Hydrated at
2026-06-01 02:52:09

Label at a glance#

ProductFerrous Sulfate
Active ingredientFERROUS SULFATE
Label structure9 sections

Dosage and administration

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

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 361% 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 (1-800-222-1222).

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 (from 324 mg of Ferrous Sulfate)65 mg361%

Other ingredients:Microcrystalline Cellulose, Methacrylic Acid Copolymer, Croscarmellose Sodium. Crospovidone, Hypromellose, Stearic Acid, Polydextrose, FD&C Red #40 Lake, Talc, Triacetin, Sodium Lauryl Sulfate, Silicon Dioxide, Triglycerides, Titanium Dioxide, Glycerol Monostearate, Triethyl Citrate, FDC Blue #2 Lake and Polysorbate 80.

16 HOW SUPPLIED

HEALTH CLAIM SECTION

Ferrous Sulfate Tablets are available as follows:

Each tablet contains 324mg of ferrous sulfate, equivalent to 65mg of elemental iron, providing 361% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

Available in bottles of 100 tablets (72789-436-01)

PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72789-436-01

Ferrous Sulfate
Enteric-Coated
Tablets

324 mg

Dietary
Supplement

Marketed and Packaged By:
PD-Rx Pharmaceuticals, Inc
Oklahoma City, OK 73127
1-405-942-3040 V.12.24.0

100 Tablets
TAMPER EVIDENT: DO NOT USE IF
SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1860100ferrous sulfate 324 MG (iron 65 MG) Delayed Release Oral TabletPSN10
1860100ferrous sulfate 324 MG Delayed Release Oral TabletSCD10
1860100ferrous sulfate 324 MG (iron 65 MG) Delayed Release Oral TabletSY10
1860100FESO4 324 MG Delayed Release Oral TabletSY10

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00372789436012(21)I20E97000001(17)230430(10)I20E97GTIN-14: 00372789436012
GTIN-12: 372789436012
UPC-A: 372789436012
EAN-13: 0372789436012
GTIN storage (14 digits): 00372789436012		72789436.jpg
BarcodeEAN-130372789436012GTIN-13: 0372789436012
EAN-13: 0372789436012
GTIN-12: 372789436012
UPC-A: 372789436012
GTIN storage (14 digits): 00372789436012		72789436.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-436-01Ferrous Sulfate100 in 1 BOTTLE, PLASTICTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-436-01EA - Each72789-4367a74c9dc-497d-4906-b1c5-90c772ebbb5c12025-02-10

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72789-43672789-436-01

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
NameUNIIKind
FERROUS SULFATE39R4TAN1VTACTIM
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
METHACRYLIC ACID1CS02G8656IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
HYPROMELLOSES3NXW29V3WOIACT
STEARIC ACID4ELV7Z65APIACT
POLYDEXTROSEVH2XOU12IEIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
TALC7SEV7J4R1UIACT
TRIACETINXHX3C3X673IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
1,2-DILINOLEOYL-3-OLEOYL-SN-GLYCEROL0NXD3O2NERIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
FD&C BLUE NO. 2--ALUMINUM LAKE4AQJ3LG584IACT
POLYSORBATE 806OZP39ZG8HIACT

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.