Label: CORVITE FE- calcium ascorbate, cholecalciferol, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, iron pentacarbonyl, magnesium malate, zinc glycinate, calcium threonate tablet, coated

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated January 7, 2022

If you are a consumer or patient please visit this version.

  • SUPPLEMENT FACTS

    Corvite FE 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

    CORVITE®FE should not be used by patients with a known hypersensitivity to any of the listed ingredients. All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias.

  • WARNINGS

    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

    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

    CORVITE® FE is 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 with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain which are usually transient.

  • 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

    CORVITE®FE is a red, oval shaped, bisected tablet imprinted with “VP060”.

  • DIRECTIONS FOR USE

    Take one tablet by mouth daily or as directed by a physician.

  • HOW SUPPLIED

    CORVITE®FE is available in bottles of 30 tablets.

    Product Code: 68025-060-30

  • STORAGE

    Store at controlled room temperature 15°-30°C (59°-86°F) [See USP]. Protect from light, moisture and avoid excessive heat. Dispense in a tight, light resistant container as defined by the USP using a child-resistant closure.

  • 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

    Vertical Logo

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

    68025-060-30

    CORVITE® FE
    Iron Supplement
    Tablets

    Multivitamin/Multimineral

    Gluten, Lactose, and Free
    Vegetarian Friendly

    30 Tablets

    VERTICAL
    PHARMACEUTICALS, LLC

    Corvite FE BL Rev. 122021
  • 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, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:68025-060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Ascorbate (UNII: 183E4W213W) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid160 mg
    Calcium Threonate (UNII: HBB4YPO93U) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Threonate5 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol1000 [iU]
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride10 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin15 ug
    Magnesium Malate (UNII: LA9X9UJA2Z) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Cation15 mg
    Zinc Glycinate (UNII: 681VJX72FE) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID700 ug
    5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (FOLIC ACID - UNII:935E97BOY8) 5-METHYLTETRAHYDROFOLIC ACID300 ug
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION150 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:68025-060-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT09/19/2013
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    scoring2
    shape
    size (solid drugs)19 mm
    Labeler - Vertical Pharmaceuticals, LLC (173169017)