CORVITE FE- calcium ascorbate, calcium threonate, ferrous asparto glycinate, iron, cholecalciferol, pyridoxine hydrochloride, folic acid, cyanocobalamin, magnesium malate and zinc glycinate tablet, coated 
Vertical Pharmaceuticals Inc.

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PRESCRIBING INFORMATION

Supplement Facts
Serving Size: 1 Tablet
Servings per Box: 30
Amount per Serving% Daily Value
*
Sumalate® (ferrous asparto glycinate) is a registered trademark of Albion International, Inc., Clearfield, Utah.
U.S. Pat. No. 6,716,814; U.S. Pat. No. 5,516,925; U.S. Pat. No. 8,007,846 and patents pending including U.S. Pat. Appl. No. 13/189,893 and U.S. Pat. Appl. No. 61/538,028
TRAACS® is a registered trademarks of Albion Laboratories, Inc.
Malates covered by U.S. Patent 6,706,904, Chelate covered by U.S. Patent 7,838,042; and patents pending.
Vitamin C (Calcium Ascorbate)160 mg267%
Calcium Threonate5 mg<1%
Sumalate® Ferrous Asparto Glycinate (Elemental Iron)*25 mg139%
Ferronyl Carbonyl Iron (Elemental Iron)125 mg694%
Vitamin D3 (Cholecalciferol)1,000 IU250%
Vitamin B6 (Pyridoxine HCI)10 mg500%
Folate (Folic Acid)1 mg250%
Vitamin B12 (Cyanocobalamin)15 mcg250%
Magnesium (as di-Magnesium Malate)15 mg3.8%
Zinc (as TRAACS® Zinc Glycinate Chelate)25 mg167%

Other Ingredients

Microcrystalline Cellulose, Di Calcium Phosphate, Croscarmellose Sodium, Acacia, Isopropyl Alcohol, Povidone K30, Purified Water, Magnesium Stearate, TriPotassium Citrate, Citric Acid, Fumed Silica, Hypromellose, Ethyl Cellulose, Titanium Dioxide, Polyethylene Glycol, FD&C Red #40 Lake, Talc, Polysorbate 80, Hydroxypropyl Cellulose, Black Iron Oxide and Vegetable Oil.

INDICATIONS AND USAGE

CORVITE® FE is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.

CONTRAINDICATIONS

CORVITE® FE is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

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.

Call your doctor about side effects. You may report side effects by calling 877-95-VERTI (877-958-3784).

PRECAUTIONS

General

Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with CORVITE ® FE. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

Folic Acid

Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.

ADVERSE REACTIONS

Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

OVERDOSAGE

The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

CLINICAL PHARMCOLOGY

Iron is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport.

Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase. Vitamin B12 is required for the maintenance of normal erythropoiesis, nucleoprotein and myelin synthesis, cell reproduction and normal growth. Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of vitamin B12 from the gastrointestinal tract.

DESCRIPTION

Red, oval bisected tablets embossed "VP042".

DOSAGE ANO ADMINISTRATION

Usual adult dose is 1 tablet daily, or as prescribed by a physician.

HOW SUPPLIED

CORVITE ® FE available in carton unit dose pack of 30 (3 child resistant blister cards of 10 tablets per card). 68025-042-30

STORAGE

Store at controlled room temperature 1 5°-30°C (59°-86°F) [See USP]. Protect from light, moisture and excessive heat. Dispense in a tight, light resistant container as defined in the USP using a child-resistant closure.

KEEP THIS PRODUCT OUT OF REACH OF CHILOREN.

Rx Only.

Manufactured for:
Vertical Pharmaceuticals, Inc.
Sayreville, NJ 08872

PRINCIPAL DISPLAY PANEL - 3 Blister Pack Carton

68025-042-30

Rx Only

CORVITE®FE
Tablets

Iron Supplementation

VERTICAL
PHARMACEUTICALS, INC.

Principal Display Panel - 3 Blister Pack Carton
CORVITE FE 
calcium ascorbate, calcium threonate, ferrous asparto glycinate, iron, cholecalciferol, pyridoxine hydrochloride, folic acid, cyanocobalamin, magnesium malate, and zinc glycinate tablet, coated
Product Information
Product TypeItem Code (Source)NDC:68025-042
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Ascorbate (Ascorbic Acid) Ascorbic Acid160 mg
Calcium Threonate (Calcium Cation) Calcium Threonate5 mg
Ferrous Asparto Glycinate (Ferrous Cation) Ferrous Cation25 mg
Iron (Iron) Iron125 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol1000 [iU]
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride10 mg
Folic Acid (Folic Acid) Folic Acid1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin15 ug
Magnesium Malate (Magnesium Malate) Magnesium Malate15 mg
Zinc Glycinate (Zinc Cation) Zinc Glycinate25 mg
Inactive Ingredients
Ingredient NameStrength
Cellulose, Microcrystalline 
Calcium Phosphate 
Croscarmellose Sodium 
Acacia 
Isopropyl Alcohol 
Povidone K30 
Water 
Magnesium Stearate 
Potassium Citrate Anhydrous 
Citric Acid Monohydrate 
Silicon Dioxide 
Hypromelloses 
Ethylcelluloses 
Titanium Dioxide 
Polyethylene Glycols 
FD&C Red No. 40 
Aluminum Oxide 
Talc 
Polysorbate 80 
Hydroxypropyl Cellulose (Type H) 
Ferrosoferric Oxide 
Corn Oil 
Product Characteristics
ColorREDScore2 pieces
ShapeOVALSize19mm
FlavorImprint Code VP042
Contains    
Packaging
#Item CodePackage Description
1NDC:68025-042-303 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT12/31/2010
Labeler - Vertical Pharmaceuticals Inc. (173169017)
Establishment
NameAddressID/FEIBusiness Operations
Viva Pharmaceuticals253288898MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions108660077PACK
Establishment
NameAddressID/FEIBusiness Operations
Blispak Inc.094902235PACK
Establishment
NameAddressID/FEIBusiness Operations
Nutramed022004902PACK

Revised: 03/2013
 
Vertical Pharmaceuticals Inc.