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Virt-Gard


HEALTH CLAIM SECTION

76439-353-10

Rx

Prescription Folic Acid-Containing Dietary Supplement


DESCRIPTION

Virt-Gard is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

Other Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Pregelatinized Starch, Pink Coating (Hypromellose, Polydextrose, Titanium Dioxide, Talc, Maltodextrin, Medium Chain Triglycerides, FD&C Red #40, FD&C Yellow #6, FD&C Blue #1), Stearic Acid, Silicon Dioxide, Magnesium Stearate.

Vitamin B6
(Pyridoxine HCl)25 mg  1471%
Folate(2200 mcg Folic Acid)3667 mcg DFE    917%
Vitamin B12
(Cyanocobalamin)1 mg41667%
*Percent Daily Values are based on a 2,000 calorie diet.

INDICATIONS AND USAGE

Virt-Gard tablets are indicated for nutritional support and folic acid supplementation. This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.


CONTRAINDICATIONS

This product is contraindicated in people with known history of hypersensitivity to any of the ingredients.


CAUTIONS

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).


Pediatric Use

Safety and effectiveness in pediatric patients have not been established.


SIDE EFFECTS

Allergic sensitization has been reported following oral administration of folic acid. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride.

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


DIRECTIONS FOR USE (Adults)

1 tablet daily or as directed by a licensed medical practitioner.


HOW SUPPLIED

Supplied as round, pink tablets imprinted with "V353," dispensed in bottles of 100 tablets.

76439-353-10


STORAGE

Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

Call your licensed medical practitioner about side effects. You may report side effects by calling Virtus at 1-855-255-6076.

KEEP OUT OF REACH OF CHILDREN.

Rx

Manufactured for:Virtus Pharmaceuticals OPCO II, LLCNashville, TN 372171-855-255-6076

Made in USA

Rev. 06/2018