Ferrous Sulfate Enteric-Coated Tablets

Manufacturer
Upsher-Smith Laboratories. LLC
Effective date
2024-04-15
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:51:02

Label at a glance#

ProductFerrous Sulfate Enteric-Coated
Active ingredientFerrous Sulfate
Label structure9 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. Tablets are enteric-coated to help protect your stomach.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size 1 Tablet
Amount per Serving% Daily Value
Iron
(as dried ferrous sulfate)
65 mg361%

Other 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.

Contains: Milk

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.

Tablets are enteric-coated to help protect your stomach.

SAFE HANDLING WARNING SECTION

Store in a cool, dry place. Protect contents from light and moisture.

Caution

PRECAUTIONS 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 the advice of a health professional before using this product.

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.

HEALTH CLAIM SECTION

DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN, OR MISSING.

Questions or comments?

HEALTH CLAIM SECTION

1-800-650-3789 Mon–Fri 8am to 5pm CST

HEALTH CLAIM SECTION

Distributed by
UPSHER-SMITH LABORATORIES, LLC
Maple Grove, MN 55369

© 2024 Upsher-Smith Laboratories, LLC

CC8-02450108-11
133R R0324

PRINCIPAL DISPLAY PANEL - 325 mg Blister Pack Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

List 0245-0108-11

Ferrous Sulfate
Enteric-Coated
Tablets

Dietary Supplement

325 mg

100 Tablets

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 325 mg Blister Pack Label
PRINCIPAL DISPLAY PANEL - 325 mg Blister Pack Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310324ferrous sulfate 325 MG (iron 65 MG) Delayed Release Oral TabletPSN2
310324ferrous sulfate 325 MG Delayed Release Oral TabletSCD2
310324ferrous sulfate 325 MG (iron 65 MG) Delayed Release Oral TabletSY2
310324FESO4 325 MG Delayed Release Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-0108-01Ferrous SulfateEnteric-Coated4 in 1 CARTONTABLET42
0245-0108-10Ferrous SulfateEnteric-Coated1000 in 1 BOTTLETABLET10002
0245-0108-11Ferrous SulfateEnteric-Coated100 in 1 BOTTLETABLET1002
0245-0108-89Ferrous SulfateEnteric-Coated25 in 1 BLISTER PACKTABLET252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0108FERROUS SULFATE ENTERIC-COATED (FERROUS SULFATE) TABLET [UPSHER-SMITH LABORATORIES. LLC]24 package rows20240417_2599d1ec-8a3e-47a2-a6c4-94d30ecf8038.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0108-01EA - Each0245-0108ed59745f-109b-4e24-a724-e4408a37a8c912024-05-16
0245-0108-10EA - Each0245-0108795a56d0-e8ef-46a9-83f9-1a9a7769ebb712024-05-16
0245-0108-11EA - Each0245-0108a4d43505-3c93-4f61-9c0a-f6cbf611b87712024-05-16
0245-0108-89EA - Each0245-0108b65912bd-6bd7-41a0-86f3-b77115dc333712024-05-16

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0245-01080245-0108-11, 0245-0108-10, 0245-0108-89, 0245-0108-01

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
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.