FDA.reportPublic FDA data

Ferrous Sulfate

Manufacturer
RedPharm Drug, Inc.
Effective date
2020-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:03:18

Label at a glance#

ProductFerrous Sulfate
Active ingredientFERROUS SULFATE
Label structure11 sections

Dosage and administration

One tablet daily or as directed by a physician. For children under 12, consult a physical before using this product. Do not exceed recommended dosage. Do not use except under the advice and supervision of a physician.

Storage and handling

Store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

EACH TABLET CONTAINS:

Amount per tablet Iron 65 mg

% Daily Value 361%

Dried Ferrous Sulfate, equivalent to 325 mg Ferrous Sulfate per tablet.

INACTIVE INGREDIENT SECTIONS

INACTIVE INGREDIENT SECTION

Other ingredients for Red Tablets: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, FD&C red #40 aluminum lake, magnesium stearate, titanium dioxide, polyethylene glycol (PEG) 8000, carnauba wax

Other ingredients for Green Tablets: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, sodium starch glycolate, hypromellose, stearic acid, polyethylene glycol (PEG) 400, magnesium stearate, riboflavin, FD&C bule #1 aluminum lake, titanium dioxide, FD&C blue #2 aluminum lake, polyethylene glycol (PEG) 8000, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, carnauba wax

PURPOSE

OTC - PURPOSE SECTION

Dietary Supplement

USE(S)

INDICATIONS & USAGE SECTION

One tablet daily or as directed by a physician. For children under 12, consult a physician before using this product.

WARNINGS

WARNINGS SECTION

Iron may interfere with absorpiton of certain antibiotics; these products should not be taken within two hours of each other.

Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking iron with meals. Iron-containing products may occassionally cause constipation or diarrhea. If pregnant or nursing consult a physicial before using this product.

DO NOT USE

OTC - DO NOT USE SECTION

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

OTHER REQUIRED WARNINGS

WARNINGS SECTION

The information on this label has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, trea, cure or prevent any disease.

To report a serious adverse event or to obtain product information, contact 800-818-4555.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN 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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

One tablet daily or as directed by a physician. For children under 12, consult a physical before using this product.

Do not exceed recommended dosage.

Do not use except under the advice and supervision of a physician.

STORAGE

STORAGE AND HANDLING SECTION

Store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FERROUS SULFATEFERROUS SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletPSN3
310325ferrous sulfate 325 MG Oral TabletSCD3
310325ferrous sulfate 324 MG (iron 65 MG) Oral TabletSY3
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletSY3
310325FESO4 325 MG Oral TabletSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1555-32022-01-28C16284748780-1d6a99b39-6c09-a426-e053-dadaa90af4c26806aeb1-8f2e-af84-e053-2991aa0a0c7b
67296-1555-62022-01-28C16284748780-1d6a99b39-6c09-a426-e053-dadaa90af4c26806aeb1-8f2e-af84-e053-2991aa0a0c7b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1555-3Ferrous Sulfate30 in 1 BOTTLETABLET, FILM COATED303
67296-1555-6Ferrous Sulfate60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1555FERROUS SULFATE TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 2 package rows20200121_6806aeb1-8f2e-af84-e053-2991aa0a0c7b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-070-01EA - Each57664-070f8f5b771-24d6-4924-93ef-1b14cbb0d89512015-01-05
57664-070-10EA - Each57664-070945c8086-99ad-448c-b3e1-02e5ec206a1912015-01-05

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-155567296-1555-3, 67296-1555-6
57664-070

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
CARNAUBA WAXR12CBM0EIZIACT
RIBOFLAVINTLM2976OFRIACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
STEARIC ACID4ELV7Z65APIACT
HYPROMELLOSES3NXW29V3WOIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FERROUS SULFATE39R4TAN1VTACTIM
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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
9c9f9120-2ba5-48ce-e053-2995a90a0b766806aeb1-8f2e-af84-e053-2991aa0a0c7b2020-01-20WarningsExact identifier
spl id: 9c9f9120-2ba5-48ce-e053-2995a90a0b76
spl set id: 6806aeb1-8f2e-af84-e053-2991aa0a0c7b

Reported adverse events (FAERS/openFDA)#

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