CORVITA 150- iron, folic acid, ascorbic acid, pyridoxine hydrochloride, cyanocobalamin and citrate tablet 
Trigen Laboratories, LLC

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CORVITA TM 150 TABLETS

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. 

 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.

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
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)

Revised: 12/2021
Document Id: 46176d16-8a8b-43f9-b471-b91b2ee04f33
Set id: d9b39d69-9a98-4da8-84bf-b0495879d5b1
Version: 4
Effective Time: 20211223
 
Trigen Laboratories, LLC