CORVITA- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, pantothenic acid, iron, magnesium oxide, zinc oxide, selenomethionine, copper gluconate, chromium picolinate, thioctic acid, lutein, and lycopene tablet, coated

Corvita by

Drug Labeling and Warnings

Corvita by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLEMENT FACTS

Other Ingredients: Silicified Microcrystalline Cellulose, Microcrystalline Cellulose, Green Color Coating (Hydroxypropylmethyl Cellulose, Titanium Dioxide, Polyvinyl Alcohol, Triacetin, Talc, FD&C Yellow #5 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake), Croscarmellose Sodium, Fumed Silica, Tri- Potassium Citrate, Magnesium Stearate, Stearic Acid, and Citric Acid.

Sugar, Lactose, and Gluten Free

CORVITA™ is a prescribed Multivitamin/Mineral Supplement with Iron that is specially formulated and indicated for the distinct nutritional requirements of individuals with vitamin deficiencies.

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.

CONTRAINDICATIONS

CORVITA™ Multivitamin/Mineral Supplement 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

 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 alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily, may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

DRUG INTERACTIONS

CORVITA™ Multivitamin & Mineral Supplement 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. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

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.

DESCRIPTION

CORVITA™ is a green coated, oval shaped tablet debossed with “VP 011”on one side, bisect on the other side.

DIRECTIONS FOR USE

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), excursion 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.

HEALTH CLAIM

KEEP OUT OF REACH OF CHILDREN.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-877-482-3788 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Customer Service: 1-877-482-3788                                                               

PLR-CORVITA-00001-01 Rev. 12/2019

Manufactured for:                                                                                             
Trigen Laboratories, LLC
Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

13811-028-10

CORVITA™ TABLETS

MULTIVITAMIN / MINERAL SUPPLEMENT WITH IRON

Sugar, Lactose and Gluten Free

100 TABLETS

INGREDIENTS AND APPEARANCE

CORVITA 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, pantothenic acid, iron, magnesium oxide, zinc oxide, selenomethionine, copper gluconate, chromium picolinate, thioctic acid, lutein, and lycopene tablet, coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-028
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.beta.-carotene (UNII: 01YAE03M7J) (.beta.-carotene - UNII:01YAE03M7J)	.beta.-carotene	750 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL SUCCINATE, D-	125 [iU]
cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41)	cholecalciferol	315 [iU]
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R)	ascorbic acid	375 mg
thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	Thiamine	25 mg
riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR)	riboflavin	3.4 mg
niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4)	niacinamide	35 mg
folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8)	folic acid	1.25 mg
pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z)	pyridoxine Hydrochloride	35 mg
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04)	Biotin	75 ug
Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737)	Pantothenic Acid	5 mg
cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204)	cyanocobalamin	70 ug
Magnesium oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	Magnesium oxide	35 mg
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	35 mg
SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70)	SELENIUM	125 ug
Chromium picolinate (UNII: S71T8B8Z6P) (CHROMIC CATION - UNII:X1N4508KF1)	CHROMIC CATION	150 ug
Copper gluconate (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	13 mg
Lutein (UNII: X72A60C9MT) (Lutein - UNII:X72A60C9MT)	Lutein	350 ug
Lycopene (UNII: SB0N2N0WV6) (Lycopene - UNII:SB0N2N0WV6)	Lycopene	125 ug
THIOCTIC ACID (UNII: 73Y7P0K73Y) (THIOCTIC ACID - UNII:73Y7P0K73Y)	THIOCTIC ACID	10 mg

Inactive Ingredients
Ingredient Name	Strength
Cellulose, Microcrystalline (UNII: OP1R32D61U)
croscarmellose sodium (UNII: M28OL1HH48)
titanium dioxide (UNII: 15FIX9V2JP)
potassium citrate anhydrous (UNII: 86R1NVR0HW)
stearic acid (UNII: 4ELV7Z65AP)
magnesium stearate (UNII: 70097M6I30)
citric acid monohydrate (UNII: 2968PHW8QP)
talc (UNII: 7SEV7J4R1U)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TRIACETIN (UNII: XHX3C3X673)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		03/01/2011

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
scoring	2
shape
size (solid drugs)	19 mm

Labeler - Trigen Laboratories, LLC (830479668)