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Corvita

TRIGEN Laboratories, Inc.

CORVITA™ Multivitamin & Mineral Supplement with Iron


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Sugar, Lactose & Gluten Free

Rx Only

CORVITA DESCRIPTION

CORVITA™ is a green, oval bisected tablet debossed "VP011". CORVITA™ is a prescription only multivitamin/mineral with iron tablet specially formulated for prophylactic or therapeutic nutritional supplementation in physiological stressful conditions.

Supplement Facts
Servings per Bottle: 100
Serving Size: 1 tablet
Each tablet contains:
% DV Adults & 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, Micronized 13 mg 72%
Alpha lipoic Acid 10 mg Daily value not established.
Lutein 5% 7 mg plant based
Lycopene 5% 2.5 mg plant based

Inactive Ingredients: silicified microcrystalline cellulose, microcrystalline cellulose, croscarmellose sodium, hypromellose, titanium dioxide, fumed silica, tripotassium citrate, stearic acid, magnesium stearate, citric acid, polyethylene glycol, ethyl cellulose, talc, polysorbate 80, FD&C yellow #5 lake, vegetable oil, black iron oxide, hydroxypropyl cellulose, FD&C blue #1 lake.

CORVITA INDICATIONS AND USAGE

CORVITA™ Multivitamins/Minerals with Iron tablets are indicated for the distinctive nutritional requirements of persons being treated for vitamin deficiencies by a physician.

CORVITA CONTRAINDICATIONS

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

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

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

DRUG INTERACTIONS

CORVITA™ Multivitamins/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.

CORVITA ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained in CORVITA™. 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.

CORVITA DOSAGE AND ADMINISTRATION

Usual adult dosage is one bisected tablet daily, or as prescribed by a physician

HOW SUPPLIED

CORVITA™ tablets are supplied in bottles of 100 tablets.

Product Code: 13811-028-10

STORAGE

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

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

All prescriptions using this product shall be pursuant to statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

KEEP OUT OF REACH OF CHILDREN.

Rx Only

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

Rev. 04/13

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

13811-028-10
Rx Only

CORVITA
TABLETS

MULTIVITAMIN / MINERAL SUPPLEMENT WITH IRON

Sugar, Lactose & Gluten Free

100 TABLETS

TRIGEN
LABORATORIES

Corvita

Corvita

.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, .Alpha.-Lipoic Acid, Lutein, and Lycopene TABLET, COATED

Product Information

Product Type Dietary supplement Item Code (Source) NDC:13811-028
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
.ALPHA.-LIPOIC ACID .ALPHA.-LIPOIC ACID 10 mg
LUTEIN 7 mg
LYCOPENE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
HYPROMELLOSES
titanium dioxide
Potassium Citrate Anhydrous
STEARIC ACID
MAGNESIUM STEARATE
CITRIC ACID MONOHYDRATE
POLYETHYLENE GLYCOLS
ETHYLCELLULOSES
talc
polysorbate 80
FD&C YELLOW NO. 5
ALUMINUM OXIDE
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE (TYPE H)
FD&C BLUE NO. 1

Product Characteristics

Color Size Imprint Code Shape
GREEN 19 mm VP011 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-028-10 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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