Ferrous Sulfate

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2025-07-07
Label type
DIETARY SUPPLEMENT
Version
8
Source
daily-update
Hydrated at
2026-08-25 01:03:34

Label at a glance#

ProductFerrous Sulfate Enteric Coated
Active ingredientFERROUS SULFATE
Label structure8 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, 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, FD&C Blue #2 Lake and Polysorbate 80.

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.

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.

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.

Storage

HEALTH CLAIM SECTION

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]

HEALTH CLAIM SECTION

You may report side effects by calling 1-844-221-7294.

HEALTH CLAIM SECTION

Manufactured for:
Westminster Pharmaceuticals, LLC

Nashville, TN 37217

Rev. 02/25

R53722

LOT:
EXP:

PRINCIPAL DISPLAY PANEL - 325 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK

69367-166-04

Ferrous Sulfate
Enteric-Coated Tablets

Iron Supplement

325 mg

(5 Grains)

100 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 325 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 325 mg Tablet Bottle Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369367166041GTIN-13: 0369367166041
EAN-13: 0369367166041
GTIN-12: 369367166041
UPC-A: 369367166041
GTIN storage (14 digits): 00369367166041
ferrous-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-166-04EA - Each69367-166652b2827-b4a4-45c4-b8a5-397ade93c4a912017-11-06
69367-166-07EA - Each69367-16634409830-cd9c-4dd7-b77a-bc5299e9ae0c12017-11-06
69367-166-20EA - Each69367-16687076928-aa21-41fd-94ec-139e9b70903412025-08-11

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69367-16669367-166-04, 69367-166-07, 69367-166-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-07-07daily-update2026-07-28 05:10:18
62025-07-07full-release2026-06-01 02:51:51

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.