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 
Trigen Laboratories, LLC

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CORVITA™
Multivitamin & Mineral
Supplement with Iron

SUPPLEMENT FACTS

Supplement Facts Panel

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.

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 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.   

PLR-CORVITA-00001-02 Rev. 12/2021

Manufactured for:                                                                                             TRIGEN LOGO
Trigen Laboratories, LLC
Alpharetta, GA 30005

1-770-509-4500

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

13811-028-10

CORVITATABLETS

MULTIVITAMIN / MINERAL SUPPLEMENT WITH IRON

Sugar, Lactose and Gluten Free

100 TABLETS

Corvita BL Rev. 12/2021
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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-028
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE750 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL SUCCINATE, D-125 [iU]
cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41) cholecalciferol315 [iU]
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid375 mg
thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) Thiamine25 mg
riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR) riboflavin3.4 mg
niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4) niacinamide35 mg
folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid1.25 mg
pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (pyridoxine - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride35 mg
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin75 ug
Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid5 mg
cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin70 ug
Magnesium oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium oxide35 mg
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide35 mg
SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70) SELENIUM125 ug
Chromium picolinate (UNII: S71T8B8Z6P) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIC CATION150 ug
Copper gluconate (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON13 mg
Lutein (UNII: X72A60C9MT) (Lutein - UNII:X72A60C9MT) Lutein350 ug
Lycopene (UNII: SB0N2N0WV6) (Lycopene - UNII:SB0N2N0WV6) Lycopene125 ug
THIOCTIC ACID (UNII: 73Y7P0K73Y) (THIOCTIC ACID - UNII:73Y7P0K73Y) THIOCTIC ACID10 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-028-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT03/01/2011
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
imprint
scoring2
shape
size (solid drugs)19 mm
Labeler - Trigen Laboratories, LLC (830479668)

Revised: 12/2021
Document Id: 804eeb2b-a872-4a46-9502-ad04d97dfe61
Set id: c920c091-1eef-49e1-a697-eb5bf6aae145
Version: 8
Effective Time: 20211220
 
Trigen Laboratories, LLC