Label: CORVITA 150- iron, folic acid, ascorbic acid, pyridoxine hydrochloride, cyanocobalamin and citrate tablet

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

Drug Label Information

Updated December 23, 2021

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

  • SUPPLEMENT FACTS

    Corvita 150 Supplement Facts

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


    GLUTEN-, LACTOSE- AND SUGAR-FREE

     
    CORVITA™ 150 is a prescription multivitamin/multimineral supplement used to improve the nutritional status of patients with iron deficiency

  • CONTRAINDICATIONS

    CORVITA™ 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 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 CORVITA™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.

  • DRUG INTERACTIONS

    CORVITA™150 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. 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

    CORVITA™ 150 is a red, oval bisected tablet imprinted with “VP031”.

  • DIRECTIONS FOR USE

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

  • HOW SUPPLIED

    CORVITA™ 150 tablets are supplied in unit dose packs of 100 (10 blister cards of 10 tablets each).

    PRODUCT CODE 13811-066-10

  • STORAGE

    Store at 20°-25°C (68°-77°F), excursions 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 in the USP using a child-resistant closure.

  • HEALTH CLAIM

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


    PLR-CORVITA150-00001-1                                                                          Rev. 12/2021

    Manufactured for:
    Trigen Laboratories, LLC
    Alpharetta, GA 30005

    www.trigenlab.com

    Trigen Logo

  • PRINCIPAL DISPLAY PANEL - 100 Tablets Blister Label

    13811-066-10

    CORVITA TM 150
    TABLETS

    Iron Supplementation

    Gluten-, Lactose-, and Sugar-Free

    Corvita 150 Carton Rev. 122021
  • INGREDIENTS AND APPEARANCE
    CORVITA 150 
    iron, folic acid, ascorbic acid, pyridoxine hydrochloride, cyanocobalamin and citrate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-066
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron150 mg
    Folic Acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) Folic Acid1.25 mg
    ascorbic acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ascorbic acid120 mg
    pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride10 mg
    Cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) Cyanocobalamin15 ug
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC25 mg
    Inactive Ingredients
    Ingredient NameStrength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-066-1010 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT07/13/2013
    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)