FERIVA FA- ferrous bisglycinate, ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium capsule, gelatin coated

FeRiva FA by

Drug Labeling and Warnings

FeRiva FA by is a Prescription medication manufactured, distributed, or labeled by Avion Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Iron Supplement

Rx Only Dietary Supplement

DESCRIPTION

DESCRIPTION: FeRiva FA ® is a prescription iron supplement. FeRiva FA ® is a red gel capsule.

INACTIVE INGREDIENT

OTHER INGREDIENTS: Silicon dioxide and magnesium stearate. Gel capsule: (bovine gelatin, titanium dioxide, FD&C blue #1 and FD&C red #40).

INDICATIONS & USAGE

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

CONTRAINDICATIONS

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

BOXED WARNING

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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

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

PEDIATRIC USE: Safety and effectiveness have not been studied in pediatric patients.

ADVERSE REACTIONS

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

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Adults, one (1) capsule daily, with or without food, or as prescribed by your healthcare provider. Do not administer to children under the age of 12.

HOW SUPPLIED

HOW SUPPLIED: In child-resistant bottles of 30 capsules (75854-319-30). The listed product number is not a National Drug Code, but has instead been formatted to comply with standard industry practice for pharmacy computer systems.

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, GA 30022

1-888-61-AVION

Rev. 0915-01

Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 6,716,814, 8,007,846, and 8,425,956.

Ferrochel ® is a registered trademark of Albion Laboratories, Inc. covered by U.S. Patents 6,716,814 & 7,838,042.

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

75854-0319-30

FeRivaFA ™

Iron Supplement

30 Capsules

Rx Only

Avion
PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

FERIVA FA 
ferrous bisglycinate, ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 75854-319
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	36.7 mg
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	36.7 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	36.7 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	175 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	300 ug
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1.5 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75854-319-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2015

Labeler - Avion Pharmaceuticals, LLC (040348516)

Establishment
Name	Address	ID/FEI	Business Operations
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-319)