FDA.reportPublic FDA data

OneVITE Pediatric Fe-Vite Brain Boost Drops

Manufacturer
Akron Pharma
Effective date
2026-04-10
Label type
DIETARY SUPPLEMENT
Version
6
Source
full-release
Hydrated at
2026-06-01 02:52:46

Label at a glance#

ProductFE-Vite Iron Oral Solution
Active ingredientFERROUS SULFATE
Label structure7 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

                                                                                            Supplement Facts
Serving Size: 1 mL Daily
Serving per container:  50
Amount per 1 mL (dropperful)                                                                               % Daily Value
                                                                              Infants through 12 Months of age         Children 1 through 4 years of age
Iron (as Ferrous Sulfate)   15 mg                                                     100%                                                  150%

HEALTH CLAIM SECTION

Although nutrition improvement have significantly reduced the incidence of iron deficiency, the condition continue to affect many young children.*

One daily dose of Pediatric Iron drops has 100% DV of iron for infants and 150% DV for children age of 1-4 Years.

* This statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease.

SAFE HANDLING WARNING SECTION

Storage:  Store at room temperature 15º -30ºC(59º - 86ºF).  Protect from freezing.  After opening, store away from direct light.  Refrigerator is not required.

WARNINGS SECTION

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.

PRECAUTIONS SECTION

SHAKE WELL BEFORE USE.

DOSAGE & ADMINISTRATION SECTION


Directions for use:

Administer this supplement using only the device provided.  Shake bottle well and fill dropper to 1.0 ml. line.  Dosage not to exceed 1.0 ml. per day unless doctor recommends another dosage.  Dispense directly into mouth or mixed with formula, fruit juice, cereal, or other foods.  Rinse and retain device for further dosing of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FE-Vite Container Label

LabelLabel

FE-Vite Carton-Container Label

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251156ferrous sulfate 75 MG (iron 15 MG) in 1 mL Oral SolutionPSN6
251156ferrous sulfate 75 MG/ML Oral SolutionSCD6
251156ferrous sulfate 75 MG (iron 15 MG) per 1 ML Oral SolutionSY6
251156FESO4 75 MG/ML Oral SolutionSY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371399748058GTIN-13: 0371399748058
EAN-13: 0371399748058
GTIN-12: 371399748058
UPC-A: 371399748058
GTIN storage (14 digits): 00371399748058		FE-VITE-crtn.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-7480-5FE-Vite Iron Oral Solution50 mL in 1 BOTTLE, DROPPERSOLUTION506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-7480-5ML - Milliliter71399-7480a616d825-95de-45d8-9f89-920d4daef07312022-03-09

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-748071399-7480-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROUS SULFATE39R4TAN1VTACTIM
SUCROSEC151H8M554IACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARAMELT9D99G2B1RIACT
WATER059QF0KO0RIACT

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.