FERROUS SULFATE TABLETS 325 mg (5 gr)

Manufacturer
Bryant Ranch Prepack
Effective date
2017-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:14

Label at a glance#

ProductFERROUS SULFATE
Active ingredientFERROUS SULFATE
Label structure10 sections

Dosage and administration

Each tablet contains: Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.

Label contents#

Full prescribing information#

Supplement Facts[/S]

SPL UNCLASSIFIED SECTION

 Serving Size: 1 Tablet
Amount per Tablet
 % Daily Value
 Iron (as ferrous sulfate)  65 mg  360 %

SUGGESTED USE

INDICATIONS & USAGE SECTION

Adults: One (1) tablet daily, preferably after meals or as directed by the doctor. Children: As directed by the doctor.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

EACH TABLET CONTAINS:                  % U.S. RDA*

Elemental Iron 65 mg     360

(Equivalent to 325 mg of Ferrous Sulfate)

* U.S. Recommended Daily Allowance  

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide

Purpose

OTC - PURPOSE SECTION

Iron Supplement

WARNING:

WARNINGS SECTION

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.

WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea.

As with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product.   

DRUG INTERACTION PRECAUTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Each tablet contains: Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.

Questions or Comments

OTC - QUESTIONS SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR DAMAGED

Distributed by: Qualitest Pharmaceuticals, Inc.

340B FERROUS SULFATE 325MG TABLET

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-6823-12021-04-27C16284748780-19d75b9d1-0639-f424-e053-dadaa90a57ceFERROUS SULFATE TABLETS 325 mg (5 gr)
63629-6823-12020-01-31C16284748780-19d75b9d1-0639-f424-e053-dadaa90a57ceFERROUS SULFATE TABLETS 325 mg (5 gr)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-0179-29EA - Each0603-0179f0befba3-dfd8-4802-b018-22176eb8b62712013-05-02
0603-0179-32EA - Each0603-0179434849ae-04dd-4d7c-bc36-8b996820468912013-05-02

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63629-682363629-6823-1
0603-0179

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
63eb1f97-1bbe-44e6-978a-b7c3adaf36a17a809928-e4e8-4733-8dca-1f4aa95ab9482021-04-26WarningsExact identifier
spl set id: 7a809928-e4e8-4733-8dca-1f4aa95ab948

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.