FDA.reportPublic FDA data

Ferrous Sulfate Enteric-Coated Tablets

Manufacturer
Nationwide Pharmaceutical, LLC
Effective date
2024-10-11
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:51:13

Label at a glance#

ProductFerrous Sulfate 324mg Enteric Coated
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.

Label contents#

Full prescribing information#

CONTAINS

HEALTH CLAIM 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.

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 the 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.

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.

STORAGE

SAFE HANDLING WARNING SECTION

Store at 15-30°C (58-86°F)

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size: 1 Tablet
Amount Per Tablet% Daily Value
Iron (as Ferrous Sulfate)65 mg362%

Other ingredients: Microcrystalline Cellulose, Dibasic Calcium Phosphate Dihydrate, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Triacetin, FD&C Red No. 40, Silicon Dioxide, Hypromellose, Methacrylic Acid, Mineral Oil.

SAFE HANDLING WARNING 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.

HEALTH CLAIM SECTION

Manufactured for/Distributed by:
Nationwide Pharmaceutical LLC
San Antonio, TX 78216
Rev 10/2024

PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nationwide
Pharmaceutical

NDC 69375-0003-10

Ferrous Sulfate
Enteric-Coated Tablets

324 mg

Dietary Supplement

100 TABLETS

Made in the USA

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 TabletPSN2
1860100ferrous sulfate 324 MG Delayed Release Oral TabletSCD2
1860100ferrous sulfate 324 MG (iron 65 MG) Delayed Release Oral TabletSY2
1860100FESO4 324 MG Delayed Release Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69375-003-10Ferrous Sulfate 324mg Enteric Coated100 in 1 BOTTLETABLET, DELAYED RELEASE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69375-003FERROUS SULFATE 324MG ENTERIC COATED (FERROUS SULFATE) TABLET, DELAYED RELEASE [NATIONWIDE PHARMACEUTICAL, LLC]21 package rows20241024_3fbacc74-d2e6-459f-9b6e-1dbc49690fef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69375-003-10EA - Each69375-0036a67d892-12b8-40bf-a5a5-1e495c51911d12024-04-05

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69375-00369375-003-10

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
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
TRIACETINXHX3C3X673IACT
FD&C RED NO. 40WZB9127XOAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
MINERAL OILT5L8T28FGPIACT

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
generic name: FERROUS SULFATE
Ferrous SulfateFERROUS SULFATERichmond Pharmaceuticals Inc.5514d582-19b5-4f1e-b794-f790afb8211c2024-12-26Boxed warning, WarningsName fallback
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.