FDA.reportPublic FDA data

Ferrous Sulfate

Manufacturer
Pharbest Pharmaceuticals, Inc.
Effective date
2019-07-23
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:56

Label at a glance#

ProductFerrous Sulfate
Active ingredientFERROUS SULFATE
Label structure5 sections

Dosage and administration

Adults and children over 12 years age: 1 tablet daily preferably with a meal or as directed by a doctor. Children under 12 years of age: consult a doctor.  Do not exceed recommended dosage.

Label contents#

Full prescribing information#

Supplement Facts

STATEMENT OF IDENTITY SECTION

Serving Size 1 Tablet

Servings Per Container 1000

 Amount Per Serving    % Daily Value
 Iron (as ferrous sulfate) 65 mg361%

Other ingredients: croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Formula: Each tablet contains 202 mg of dried ferrous sulfate USP (65 mg of elemental iron), equivalent to 325 mg of ferrous sulfate USP.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years age: 1 tablet daily preferably with a meal or as directed by a doctor. Children under 12 years of age: consult a doctor. Do not exceed recommended dosage.

Caution:

WARNINGS SECTION

Since oral iron products interfere with absorption of certain antibiotics; these products should not be taken within two hours of each other. if you are pregnant, nursing or taking any medications, consult your doctior befoe use. Discontinue use and consult your doctor if any adverse reactions occur. 

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

SAFE HANDLING WARNING SECTION

Store at room temperature. Keep tightly closed in a cool dry place.

Questions or comments? (866) 562-2756 Mon-Fri 8 AM to 4 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

Manufactured in the USA

*Compare to the active ingredient in Feosol®

Ferrous 

Sulfate

Iron Supplement

325 mg

1000 TABLETS

Ferrous Sulfate 325 mg Green Tablet Product LabelFerrous Sulfate 325 mg Green Tablet Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletPSN1
310325ferrous sulfate 325 MG Oral TabletSCD1
310325ferrous sulfate 324 MG (iron 65 MG) Oral TabletSY1
310325ferrous sulfate 325 MG (iron 65 MG) Oral TabletSY1
310325FESO4 325 MG Oral TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-382-08Ferrous Sulfate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
16103-382-11Ferrous Sulfate1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-382FERROUS SULFATE (FERROUS SULFATE 325 MG GREEN) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]12 package rows20210401_5b363610-cd9d-4fb9-b429-e35378caf279.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-382-08EA - Each16103-38289b098e8-9d6f-4fe4-bfd1-5b2e49c1466a12021-04-08
16103-382-11EA - Each16103-38265f33516-e3cd-45a4-aaec-a5c7e1630c9312021-04-08

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16103-38216103-382-08, 16103-382-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROUS SULFATE39R4TAN1VTACTIM
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

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.