Label: CORVITE FE- calcium ascorbate, cholecalciferol, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, iron pentacarbonyl, magnesium malate, zinc glycinate, calcium threonate tablet, coated
- NHRIC Code(s): 68025-060-30
- Packager: Vertical Pharmaceuticals, LLC
- Category: DIETARY SUPPLEMENT
Drug Label Information
Updated January 7, 2022
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SUPPLEMENT FACTS
Other Ingredients: Microcrystalline Cellulose, di-Calcium Phosphate, Pregelatinized Starch, Red Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, FD&C Red #40 Lake, Glycerol Triacetate, Titanium Dioxide, Talc, FD&C Yellow #6 Lake, FD&C Blue #2 Lake), Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide and Fumed Silica.
VEGETARIAN FRIENDLY
GLUTEN, LACTOSE AND SUGAR FREE
CORVITE® FE is a professionally prescribed hematinic multivitamin/multimineral dietary supplement used to improve the nutritional status of patients with iron deficiency; this includes women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers.Other Ingredients: Microcrystalline Cellulose, DiCalcium Phosphate, Croscarmellose Sodium, Acacia, Isopropyl Alcohol, Povidone K30, Purified Water, Magnesium Stearate, TriPotassium Citrate, Citric Acid, Fumed Silica, Hypromellose, Ethyl Cellulose, Titanium Dioxide, Polyethylene Glycol, FD&C Red #40 Lake, Talc, Polysorbate 80, Hydroxypropyl Cellulose, Black Iron Oxide and Vegetable Oil.
- CONTRAINDICATIONS
- WARNINGS
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PRECAUTIONS
General: Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with CORVITE® FE. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.
Folic Acid: Folic acid alone is an 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 in that hematologic remission can occur while neurologic manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
Pediatric Use: Safety and effectiveness in pediatric population have not been established.
Geriatric Use: Safety and effectiveness in elderly population have not been established.
- DRUG INTERACTIONS
- ADVERSE REACTIONS
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OVERDOSAGE
The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
- DESCRIPTION
- DIRECTIONS FOR USE
- HOW SUPPLIED
- STORAGE
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HEALTH CLAIM
KEEP OUT OF REACH OF CHILDREN.
** Quatrefolic® is a registered trademark of Gnosis, SpA.
U.S. Patent No. 7,947,662.
***TRAACS® is a registered trademark of Albion International, Inc.
Malate covered by U.S. Patent No, 6,706,904;
Chelate covered by U.S. Patent No. 7,838,042.
Call your doctor about side effects. To report side effects, call Vertical Pharmaceuticals at 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
PLR-CFE-00003-1 Rev. 12/2021
Distributed by:
Vertical Pharmaceuticals, LLC
Alpharetta, GA 30005
www.verticalpharma.com - PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
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INGREDIENTS AND APPEARANCE
CORVITE FE
calcium ascorbate, cholecalciferol, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, iron pentacarbonyl, magnesium malate, zinc glycinate, calcium threonate tablet, coatedProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:68025-060 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium Ascorbate (UNII: 183E4W213W) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 160 mg Calcium Threonate (UNII: HBB4YPO93U) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Threonate 5 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 1000 [iU] Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 10 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 15 ug Magnesium Malate (UNII: LA9X9UJA2Z) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Cation 15 mg Zinc Glycinate (UNII: 681VJX72FE) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation 25 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 700 ug 5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (FOLIC ACID - UNII:935E97BOY8) 5-METHYLTETRAHYDROFOLIC ACID 300 ug IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 150 mg Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline (UNII: OP1R32D61U) Croscarmellose Sodium (UNII: M28OL1HH48) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Magnesium Stearate (UNII: 70097M6I30) Silicon Dioxide (UNII: ETJ7Z6XBU4) Hypromelloses (UNII: 3NXW29V3WO) Titanium Dioxide (UNII: 15FIX9V2JP) FD&C Red No. 40 (UNII: WZB9127XOA) Talc (UNII: 7SEV7J4R1U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) STARCH, CORN (UNII: O8232NY3SJ) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) TRIACETIN (UNII: XHX3C3X673) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:68025-060-30 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 09/19/2013 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color imprint scoring 2 shape size (solid drugs) 19 mm Labeler - Vertical Pharmaceuticals, LLC (173169017)