FERIVA- ferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin and biotin capsule 
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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75 mg Dual-Iron Delivery

Rx Only

DESCRIPTION: FeRiva is a prescription iron supplement. FeRiva is a white capsule with a red stripe down the middle that includes a multiphase capsule-in-capsule release system that delivers dietary ingredients at appropriate times for absorption by the body. The outer capsule delivers an immediate release of dietary ingredients while the inner capsule delivers a prolonged-release effect.

Supplement Facts
Serving Size: 1 Capsule
Each Capsule Contains:
Iron
(as Ferrous Bis-glycinate Chelate -
Ferrochel®and Carbonyl Iron - Ferronyl®)
75 mg
Vitamin C
(as PureWay-C®)
175 mg
Folic Acid1 mg
Vitamin B12
(as cyanocobalamin)
120 mcg
Biotin300 mcg

OTHER INGREDIENTS: Olive Oil, Docusate Sodium, Microcrystalline Cellulose, Water, Gelatin, FD&C Red 40, Titanium Dioxide, Polysorbate 80.

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

CONTRAINDICATIONS: FeRiva 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 years of age. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center.

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.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, dosing should start at the lower end of the dosing range.

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: FeRiva is supplied in child-resistant bottles of 30 capsules. (75854-305-30).

The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).
[See USP Controlled Room Temperature.]

Dispense in a light-resistant container to protect from light and moisture.

DISTRIBUTED BY:
Avion Pharmaceuticals, LLC
Atlanta, GA 30350
1-888-61-AVION

Ferronyl is a registered trademark of ISP Investments, Inc. PureWay-C is a registered trademark of Innovation Laboratories, Inc. Ferrochel is a registered trademark of Albion Laboratories, Inc. covered by U.S. Patents 6,716,814 & 7,838,042. Covered by one or more claims of U.S. Patent # 7,670,612 (INNERCAP Technologies, Inc).

FeRiva is a trademark of Avion Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

Rev. 01/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-305-30

FeRiva

Iron Supplement with
INNERCAP Mulip-Phase Capsule
Delivery System

30 Capsules

Rx Only

Avion
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 30 capsules
FERIVA 
ferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin, biotin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:75854-305
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS BISGLYCINATE (FERROUS CATION) FERROUS CATION75 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID175 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN120 ug
BIOTIN (BIOTIN) BIOTIN300 ug
Inactive Ingredients
Ingredient NameStrength
OLIVE OIL 
DOCUSATE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
WATER 
GELATIN 
FD&C RED NO. 40 
TITANIUM DIOXIDE 
POLYSORBATE 80 
Product Characteristics
ColorWHITE (red stripe down the middle) Scoreno score
ShapeCAPSULESize22mm
FlavorImprint Code TL019
Contains    
Packaging
#Item CodePackage Description
1NDC:75854-305-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/13/2012
Labeler - Avion Pharmaceuticals, LLC (965450542)

Revised: 05/2013
 
Avion Pharmaceuticals, LLC