Rx

76439-364-90

DESCRIPTION

Virt-Vite is an orally administered prescription dietary supplement for the management of patients requiring increased folate levels.

Virt-Vite should be administered under the supervision of a licensed medical practitioner.

Other Ingredients: Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose Ph101, Opadry II Pink 85F140140, (Polyvinyl Alcohol-Part Hydrolyzed, Titanium Dioxide, Macrogol/Peg, Talc, Carmine High Tint 50%, FD&C Blue #2/Indigo Carmine Al 3% - 5%), Croscarmellose Sodium, Opadry II Clear #Y-19-7483 (HPMC 2910/Hypromellose 6cP, Maltodextrin, HPMC 2910/Hypromellose 3cP, Macrogol/Peg 400, HPMC 2910/Hypromellose 50cP), Magnesium Stearate, NF.

Contains: FD&C Blue #2 and Carmine.

ALLERGY STATEMENTS

This product has been manufactured in a facility that also manufactures products containing milk and soy. Individuals with allergic tendencies to these substances should use discretion.

Allergic reactions have been reported following the use of oral folate.

Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cobalamin.

Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxine.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product.

CAUTION

High levels of folic acid may, especially in older adults, hide signs of vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

 

KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.

INTERACTIONS

Drugs which may interact with folate include but are not limited to:

•

First generation anticonvulsants (folate may reduce their effectiveness)

•

Capecitabine (folate may enhance its toxicity)

•

Fluorouracil (folate may enhance its toxicity)

Drugs that may interfere with folate metabolism include, but are not limited to:

•

Dihydrofolate Reductase Inhibitors.

•

Fluoxetine

•

Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

•

Sulfasalazine

•

Warfarin

Drugs which may interfere with the absorption of folate from the gastrointestinal tract or decrease plasma levels include, but are not limited to:

•

Cholestyramine

•

Colestipol

•

Oral Contraceptives

•

Methylprednisolone

•

Pancreatic Enzymes

•

Pentamidine

•

Smoking and Alcohol

•

Sulfasalazine

•

Metformin

Drugs which may interact with vitamin B6 include, but are not limited to:

•

Levodopa (the action of levodopa may be antagonized by vitamin B6)

Drugs which may interact with vitamin B12 include but are not limited to:

•

Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride (may decrease the absorption of vitamin B12).

•

Nitrous oxide (can produce a functional vitamin B12 deficiency).

PREGNANCY and NURSING MOTHERS

Virt-Vite is not intended for use as a prenatal/postnatal multivitamin for lactating or nonlactating mothers. This product contains only B vitamins. Talk with your medical practitioner before using if pregnant or lactating.

DIRECTIONS FOR USE

One to two tablets daily or as directed by a licensed medical practitioner.

STORAGE

Store at room temperature 15° to 30°C (59° to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container.

HOW SUPPLIED

Virt-Vite are supplied as round, coated, Pink colored tablets imprinted on one side with "V209", and are supplied in bottles of 90 tablets.

 

KEEP THIS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Call your medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or FDA at 1-800-FDA-1088.

76439-364-90

Rx

Manufactured for:
Virtus Pharmaceuticals OPCO II, LLC
Nashville, TN 37217
1-888-848-3593
MADE IN USA

Rev. 06/15

PC0299-01

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

76439-364-90

Virt-Vite

Prescription Folic Acid-Containing
Dietary Supplement

Rx
90 Tablets
Made in the USA