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

CORVITA 150 by

Drug Labeling and Warnings

CORVITA 150 by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 1-888-9-TRIGEN (1-877-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Customer Service: 1-888-987-4436                                                                            Rev. 07/2018

Manufactured for:
Trigen Laboratories, LLC
Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 100 Tablets Blister Label

13811-066-10

CORVITA TM 150
TABLETS

Iron Supplementation

Gluten-, Lactose-, and Sugar-Free

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-066
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	150 mg
Folic Acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	Folic Acid	1.25 mg
ascorbic acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ascorbic acid	120 mg
pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	pyridoxine Hydrochloride	10 mg
Cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	Cyanocobalamin	15 ug
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	25 mg

Inactive Ingredients
Ingredient Name	Strength
Cellulose, Microcrystalline (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOLS (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 1500, PREGELATINIZED (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-066-10	10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		07/13/2013

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
scoring	2
shape
size (solid drugs)	19 mm

Labeler - Trigen Laboratories, LLC (830479668)