FERIVAFA- ferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium capsule, gelatin coated 
Avion Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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FeRivaFAFA

Iron Supplement

110 mg Dual-Iron Delivery with Quatrefolic

Rx Only Dietary Supplement

DESCRIPTION: FeRivaFA is a prescription iron supplement. FeRivaFA™ is a red gel capsule.

Supplement Facts
Serving Size: 1 Capsule
Each Capsule Contains:
Iron
(as Ferrous Bis-glycinate Chelate -
Ferrochel ®and Carbonyl Iron - Ferronyl ®)
110 mg
Vitamin C175 mg
Folate
(as 1.1 mg Quatrefolic ®((6S)-5,-
methyltetrahydrofolate glucosamine salt* CAS
1181972-37-1) molar equivalent to 600 mcg of
Folic acid) (Folic acid, USP 400 mcg)
1 mg
Vitamin B12
(as cyanocobalamin)
12 mcg
Copper Oxide1.5 mg
Docusate Sodium50 mg

OTHER INGREDIENTS: Microcrystalline Cellulose, Gelatin, Magnesium Stearate, Silicon Dioxide, Titanium Dioxide and FD&C Red 40.

INDICATIONS: FeRivaFA is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.

CONTRAINDICATIONS: FeRivaFA is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.

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.

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and other drugs, herbs and/or supplements consumption should be considered.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION: One capsule daily with or without food or as prescribed by your healthcare provider.

HOW SUPPLIED: In child-resistant bottles of 30 capsules (75854-310-30) and as a sample in a 3-dose unit pack (75854-310-03). The listed product numbers are not National Drug Codes, but have instead been formatted to comply with standard industry practice for pharmacy computer systems.

STORAGE: Store between 20°- 25°C (68°- 77°F)

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Atlanta, GA 30022
1-888-61-AVION

Ferronyl ® is a registered trademark of ISP Investments, Inc. Ferrochel ® is a registered trademark of Albion Laboratories, Inc. covered by U.S. Patents 6,716,814 & 7,838,042. Quatrefolic ® is a registered trademark of Gnosis, SpA,covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

Rev. 0114

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-310-30

FeRivaFA

Iron Supplement

110 mg Dual-Iron Delivery

with Quatrefolic

30 Capsules

Rx Only

Avion
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 30 capsules
FERIVAFA 
ferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75854-310
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION110 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID175 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75854-310-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/02/201412/31/2015
2NDC:75854-310-033 in 1 PACKET; Type 0: Not a Combination Product01/02/201412/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/02/201412/31/2015
Labeler - Avion Pharmaceuticals, LLC (965450542)

Revised: 1/2018
 
Avion Pharmaceuticals, LLC