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FeRiva

Generic Name: ferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin and biotin
Dosage Form: capsule

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.

FeRiva
Iron Supplement with INNERCAP
Multi-Phase Capsule Delivery System

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 Acid 1 mg
Vitamin B12
(as cyanocobalamin)
120 mcg
Biotin 300 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

FeRiva 
ferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin, biotin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-305
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS BISGLYCINATE (FERROUS CATION) FERROUS CATION 75 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 175 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 120 ug
BIOTIN (BIOTIN) BIOTIN 300 ug
Inactive Ingredients
Ingredient Name Strength
OLIVE OIL  
DOCUSATE SODIUM  
CELLULOSE, MICROCRYSTALLINE  
WATER  
GELATIN  
FD&C RED NO. 40  
TITANIUM DIOXIDE  
POLYSORBATE 80  
Product Characteristics
Color WHITE (red stripe down the middle) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code TL019
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-305-30 30 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/30/2012
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 09/2013
 
Avion Pharmaceuticals, LLC



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