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

Corvite 150 by

Drug Labeling and Warnings

Corvite 150 by is a Other medication manufactured, distributed, or labeled by Vertical Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLEMENT FACTS

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

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

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 Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:68025-052
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CALCIUM THREONATE (UNII: HBB4YPO93U) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM THREONATE	5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	100 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	20 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	700 ug
5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	300 ug
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	150 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	10 mg
ZINC CITRATE (UNII: K72I3DEX9B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:68025-052-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		10/02/2013

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

Labeler - Vertical Pharmaceuticals, LLC (173169017)