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Corvite

Vertical Pharmaceuticals Inc.

CORVITE® TABLETS MULTIVITAMIN/MINERAL SUPPLEMENT WITH IRON


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

CORVITE DESCRIPTION

CORVITE® is a prescription only multivitamin/mineral with iron tablet specifically formulated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions.

PRESCRIBING INFORMATION

Supplement Facts
Amount per Serving % Daily Value
Serving Size: 1 Tablet
Servings per Container: 100
Adults and Children
4 Years or More
Vitamin A (Beta Carotene) 750 IU 15%
Vitamin E (d-Alpha Succinate) 125 IU 417%
Vitamin D3 (Cholecalciferol) 315 IU 79%
Vitamin C (Ascorbic Acid) 375 mg 625%
Vitamin B1 (Thiamine Mononitrate) 25 mg 1667%
Vitamin B2 (Riboflavin) 3.4 mg 200%
Niacin (Niacinamide) 35 mg 175%
Folic Acid 1.25 mg 313%
Vitamin B6 (Pyridoxine HCl) 35 mg 1750%
Biotin 75 mcg 25%
Pantothenic Acid 5 mg 50%
Vitamin B12 (Cyanocobalamin) 70 mcg 1167%
Magnesium (Oxide) 35 mg 9%
Zinc (Oxide) 35 mg 233%
Selenium (Selenomethionine) 125 mcg 179%
Chromium (Picolinate) 150 mcg 125%
Copper (Gluconate) 1 mg 50%
Iron (Ferronyl) 13 mg 72%
Alpha Lipoic Acid 10 mg Daily value not established
Lutein 5% 7 mg Daily value not established
Lycopene5% 2.5 mg Daily value not established

Other Ingredients

Microcrystalline Cellulose, Croscarmellose Sodium, Fumed Silica, Tripotassium Citrate, Stearic Acid, Magnesium Stearate, Citric Acid, Sheffcoat (Hydroxypropyl Cellulose, Titanium Dioxide, Polyvinyl Alcohol, Glycerol Triacetate, Talc, FD&C Yellow #5 Lake, FD&C Blue #2 and FD&C Yellow #6 Lake).

SUGAR, LACTOSE & GLUTEN FREE

CORVITE INDICATIONS AND USAGE

CORVITE® Multivitamin/ Mineral with Iron tablets are indicated for the distinctive nutritional requirements of persons being treated for vitamin deficiencies by a physician.

CORVITE DOSAGE AND ADMINISTRATION

Usual adult dose

One bisected tablet daily, or as directed by your doctor.

CORVITE CONTRAINDICATIONS

CORVITE® Multivitamin/Mineral with Iron tablets should not be used by patients with a known history of hypersensitivity to any of the listed ingredients or as directed by your physician.

PRECAUTIONS

Folic acid when taken in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

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.

DRUG INTERACTIONS

CORVITE® Multivitamin/Mineral with Iron tablets are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.

ADVERSE REACTION

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained in CORVITE®. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Call your doctor about side effects. You may report side effects by calling 1-877-95-VERTI (1-877-958-3784).

HOW SUPPLIED

CORVITE® Multivitamin/Mineral with Iron is a green, oval bisected tablet debossed "VP011" on one side. Available in a 100 count bottle.

PRODUCT CODE 68025-011-10

STORAGE

Store at controlled room temperature 15°-30°C (59°-86°F) [See USP]. Protect from light and moisture and avoid excessive heat. Dispense in a tight, light resistant container as defined by the USP with a child resistant closure.

KEEP OUT OF REACH OF CHILDREN.

Rx ONLY

PATENT PENDING

Manufactured for: Vertical Pharmaceuticals, Inc.
Sayreville, NJ 08872
www.verticalpharma.com

Rev. 11/12

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

68025-011-10
Rx Only

PATENT PENDING

CORVITE TABLETS

MULTIVITAMIN / MINERAL SUPPLEMENT WITH IRON

100 Tablets

Corvite

Corvite

.BETA.-CAROTENE, .ALPHA.-TOCOPHEROL SUCCINATE, D-, CHOLECALCIFEROL, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, BIOTIN, PANTOTHENIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, ZINC OXIDE, SELENOMETHIONINE, CHROMIUM PICOLINATE, COPPER GLUCONATE, IRON PENTACARBONYL, .ALPHA.-LIPOIC ACID, LUTEIN, and LYCOPENE TABLET, COATED

Product Information

Product Type Dietary supplement Item Code (Source) NDC:68025-011
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE .BETA.-CAROTENE 750 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- 125 [iU]
CHOLECALCIFEROL CHOLECALCIFEROL 315 [iU]
ASCORBIC ACID ASCORBIC ACID 375 mg
THIAMINE MONONITRATE THIAMINE ION 25 mg
RIBOFLAVIN RIBOFLAVIN 3.4 mg
NIACINAMIDE 35 mg
FOLIC ACID FOLIC ACID 1.25 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 35 mg
BIOTIN 75 ug
PANTOTHENIC ACID 5 mg
Cyanocobalamin CYANOCOBALAMIN 70 ug
magnesium oxide 35 mg
Zinc Oxide Zinc oxide 35 mg
Selenomethionine selenomethionine 125 ug
CHROMIUM PICOLINATE CHROMIUM PICOLINATE 150 ug
COPPER GLUCONATE 1 mg
IRON PENTACARBONYL FERROUS CATION 13 mg
.ALPHA.-LIPOIC ACID .ALPHA.-LIPOIC ACID 10 mg
LUTEIN 7 mg
LYCOPENE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
Potassium Citrate Anhydrous
STEARIC ACID
MAGNESIUM STEARATE
CITRIC ACID MONOHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE H)
titanium dioxide
POLYVINYL ALCOHOL
triacetin
talc
FD&C YELLOW NO. 5
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
GREEN 20 mm VP011 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68025-011-10 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2005-08-15


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