FDA.reportPublic FDA data

Enteric Coated Ferrous Sulfate Tablet

Manufacturer
Ulai Health LLC
Effective date
2024-11-27
Label type
DIETARY SUPPLEMENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:51:17

Label at a glance#

ProductEnteric Coated Ferrous Sulfate
Active ingredientFERROUS SULFATE
Label structure10 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving% Daily Value
Iron (as ferrous sulfate) 65 mg362%

Other ingredients: carmine, croscarmellose sodium, dicalcium phosphate, hypromellose, isomalt, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, riboflavin, rice starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, stearic acid, talc, triacetin, triglycerides

DOSAGE & ADMINISTRATION SECTION

Directions: 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

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 (800-222-1222).

WARNINGS SECTION

Warnings: 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. U.S. Consumer Product Safety Commission requires that iron-containing medicine and vitamins with iron be packaged in child-resistant closures. Parents should always use properly re-secure safety closures.

SAFE HANDLING WARNING SECTION

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

HEALTH CLAIM SECTION

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

HEALTH CLAIM SECTION

†This product is manufactured in a facility which shares manufacturing equipment used for manufacturing other product containing titanium dioxide.

HEALTH CLAIM SECTION

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

HEALTH CLAIM SECTION

Distributed by:
ULAI HEALTH LLC., Alexandria, VA 22312

Org. 1024

More Supplement Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

Manufactured in the USA

73057-411-08

Enteric Coated

IRON

Elemental Iron 65 mg

Titanium Dioxide Free†

Supports Red Blood Cell Production††

100 Tablets

Principal Display Panel - Ulai Enteric Coated Ferrous Sulfate Tablet Product LabelPrincipal Display Panel - Ulai Enteric Coated Ferrous Sulfate Tablet Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310324ferrous sulfate 325 MG (iron 65 MG) Delayed Release Oral TabletPSN3
310324ferrous sulfate 325 MG Delayed Release Oral TabletSCD3
310324ferrous sulfate 325 MG (iron 65 MG) Delayed Release Oral TabletSY3
310324FESO4 325 MG Delayed Release Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-411-08Enteric Coated Ferrous Sulfate100 in 1 BOTTLE, PLASTICTABLET, COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-411ENTERIC COATED FERROUS SULFATE (FERROUS SULFATE) TABLET, COATED [ULAI HEALTH LLC]31 package rows20241129_e039054d-db80-437e-8449-8e3306ece35a.zip

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
73057-41173057-411-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROUS SULFATE39R4TAN1VTACTIM
PIGMENT RED 591OZU993LXIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ISOMALTS870P55O2WIACT
MAGNESIUM STEARATE70097M6I30IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT
RIBOFLAVINTLM2976OFRIACT
STARCH, RICE4DGK8B7I3SIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TRIACETINXHX3C3X673IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

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.