Label: 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
- NHRIC Code(s): 13811-028-10
- Packager: Trigen Laboratories, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated December 20, 2021
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- Official Label (Printer Friendly)
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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
- CONTRAINDICATIONS
- WARNING
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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).
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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
- DIRECTIONS FOR USE
- HOW SUPPLIED
- STORAGE
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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 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
PLR-CORVITA-00001-02 Rev. 12/2021
Manufactured for:
Trigen Laboratories, LLC
Alpharetta, GA 300051-770-509-4500
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
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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, coatedProduct 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)