FE-VITE IRON ORAL SOLUTION- ferrous sulfate solution

FE-Vite Iron Oral Solution by

Drug Labeling and Warnings

FE-Vite Iron Oral Solution by is a Other medication manufactured, distributed, or labeled by Akron Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

                                                                                            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

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

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

WARNINGS

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

SHAKE WELL BEFORE USE.

DOSAGE & ADMINISTRATION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FE-VITE IRON ORAL SOLUTION 
ferrous sulfate solution

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71399-7480
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71399-7480-5	50 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		01/04/2021

Labeler - Akron Pharma (067878881)