Label: CORVITE 150- calcium ascorbate, calcium threonate, pyridoxine hydrochloride, biotin, cyanocobalamin, folic acid, 5-methyltetrahydrofolic acid, iron pentacarbonyl, magnesium oxide, and zinc citrate tablet, coated

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

Drug Label Information

Updated September 10, 2018

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

  • SUPPLEMENT FACTS

    SupplementFactsRev.062018

    Other Ingredients: Microcrystalline Cellulose, Pregelatinized Starch, di-Calcium Phosphate, Red Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, FD&C Red #40 Lake, Polyethylene Glycol, Talc, Titanium Dioxide), Croscarmellose Sodium, Stearic Acid, Magnesium Stearate


    VEGAN FRIENDLY


    GLUTEN-, LACTOSE- AND SUGAR-FREE

     
    CORVITE®150 is a prescription hematinic multivitamin/multimineral dietary supplement used to improve the nutritional status of patients with iron deficiency.

    Other Ingredients

    Microcrystalline Cellulose, Pregelatinized Starch, di-Calcium Phosphate, Red Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, FD&C Red #40 Lake, Polyethylene Glycol, Talc, Titanium Dioxide), Croscarmellose Sodium, Stearic Acid, Magnesium Stearate.

    Sugar, Lactose and Gluten Free

    Vegan Safe

  • CONTRAINDICATIONS

    CORVITE®150 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 hemolytica 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

    Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with CORVITE®150. 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 populations have not been established.


    Geriatric Use: Safety and effectiveness in elderly populations have not been established.


    Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (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

    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. Adverse reactions with iron therapy 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®150 is a red, oval shaped tablet imprinted with “VP052” on one side and bisected on the other side.

  • DIRECTIONS FOR USE

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

  • HOW SUPPLIED

    CORVITE®150 is available in bottles of 30 tablets.


    Product Code: 68025-052-30

  • STORAGE

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

  • HEALTH CLAIM

    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.


    **Quatrefolic® is a registered trademark of Gnosis, SpA. U.S. Patent No. 7,947,662.


    For use on the order of a healthcare practitioner


    Call your doctor about side effects. To report side effects, call Vertical Pharmaceuticals at 1-877-95-VERTI (1-877-958-3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


    Customer Service: 1-866-600-4799

    Rev. 06/2018

    verticallogo

    Distributed by:

    Vertical Pharmaceuticals, LLC
    Bridgewater, NJ 08807
    www.verticalpharma.com

                                                                    

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

    68025-052-30

    CORVITE®150 TABLETS

    Iron Supplement
    Multivitamin/Multimineral

    Vegan Friendly

    GLUTEN, LACTOSE, AND SUGAR FREE

    30 Tablets

    VERTICAL PHARMACEUTICALS, LLC

    BLRev062018
  • INGREDIENTS AND APPEARANCE
    CORVITE 150 
    calcium ascorbate, calcium threonate, pyridoxine hydrochloride, biotin, cyanocobalamin, folic acid, 5-methyltetrahydrofolic acid, iron pentacarbonyl, magnesium oxide, and zinc citrate tablet, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:68025-052
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CALCIUM THREONATE (UNII: HBB4YPO93U) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM THREONATE5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN100 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN20 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID700 ug
    5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID300 ug
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION150 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE10 mg
    ZINC CITRATE (UNII: K72I3DEX9B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:68025-052-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT10/02/2013
    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)