Ferrous Sulfate

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2019-02-15
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:13

Label at a glance#

ProductFerrous Sulfate
Active ingredientFERROUS SULFATE
Label structure5 sections

Dosage and administration

Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician. Children under 12 years of age: Consult a physician. Do not chew or crush tablet. Inactive Ingredients: Microcrystalline Cellulose, Dibasic Calcium Phosphate Dihydrate, Anhydrous Lactose, Hypromellose Phthalate, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Triacetin, FD&C Red #40...

Label contents#

Full prescribing information#

Supplement Facts

STATEMENT OF IDENTITY SECTION

Serving Size: 1 Tablet
Amount %Daily
Per Tablet Value
Iron (as dried ferrous sulfate)…………….…65mg…………………….361%

Ferrous Sulfate Enteric-Coated Tablets Iron Supplement

Warnings

WARNINGS SECTION

Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Iron-containing products may cause constipation or diarrhea. As with any dietary supplement, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: Take one tablet daily, preferably after a meal, or as directed by a physician.

Children under 12 years of age: Consult a physician. Do not chew or crush tablet.

Inactive Ingredients:

Microcrystalline Cellulose, Dibasic Calcium Phosphate Dihydrate, Anhydrous Lactose, Hypromellose Phthalate, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Triacetin, FD&C Red #40 Aluminum Lake, Colloidal Silicon Dioxide, Titanium Dioxide, Hypromellose, Mineral Oil.

Other Information:

SAFE HANDLING WARNING SECTION

• Store in a cool, dry place at controlled room temperature

15-30ºC (58-86ºF)

• Protect from moisture

• Store in original container for better identification

• Use by expiration date on package

• Tablets are enteric-coated to help protect your stomach.

Contains the following:

• Sodium: 0.83mg per tablet

• Calcium: 11.04mg per tablet

• Magnesium: 0.21mg per tablet

• Potassium 0.006mg per tablet

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0161-01
Ferrous Sulfate
Enteric-Coated Tablets
Dietary
Supplement
325 mg

100 TABLETS

PRINCIPAL DISPLAY PANEL NDC 10135-0161-01 Ferrous Sulfate Enteric-Coated Tablets Dietary Supplement 325 mg 100 TABLETSPRINCIPAL DISPLAY PANEL NDC 10135-0161-01 Ferrous Sulfate Enteric-Coated Tablets Dietary Supplement 325 mg 100 TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310324ferrous sulfate 325 MG (iron 65 MG) Delayed Release Oral TabletPSN1
310324ferrous sulfate 325 MG Delayed Release Oral TabletSCD1
310324ferrous sulfate 325 MG (iron 65 MG) Delayed Release Oral TabletSY1
310324FESO4 325 MG Delayed Release Oral TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-161-01Ferrous Sulfate100 in 1 BOTTLETABLET, COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-161FERROUS SULFATE TABLET, COATED [MARLEX PHARMACEUTICALS INC]11 package rows20190214_dae4d4d1-e431-427b-b31f-57a5462fa9a1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-161-01EA - Each10135-16139853223-c702-4599-b1b3-88be8570973e12019-03-12

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
10135-16110135-161-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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.