FE-VITE IRON ORAL SOLUTION- ferrous sulfate solution 
Akron Pharma

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FE-VITE
Pediatric Drops

                                                                                            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%

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.

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

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.

SHAKE WELL BEFORE USE.


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.

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FE-VITE IRON ORAL SOLUTION 
ferrous sulfate solution
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71399-7480
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARAMEL (UNII: T9D99G2B1R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:71399-7480-550 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement01/04/2021
Labeler - Akron Pharma (067878881)

Revised: 3/2023
Document Id: 90faf59a-8ad6-4880-9d61-93e41b33baa6
Set id: 73d1f079-d8eb-44f4-b33d-05fb25b80c8f
Version: 3
Effective Time: 20230318
 
Akron Pharma