VIRT-GARD- pyridoxine hydrochloride, folic acid, and cyanocobalamin tablet

Virt-Gard by

Drug Labeling and Warnings

Virt-Gard by is a Other medication manufactured, distributed, or labeled by Virtus Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

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.

Supplement Facts
Serving Size: 1 Tablet
	Amount Per Serving	% Daily Value*
Vitamin B6
(Pyridoxine HCl)	25 mg	1471%
Folate (2200 mcg Folic Acid)	3667 mcg DFE	917%
Vitamin B12
(Cyanocobalamin)	1 mg	41667%
*Percent Daily Values are based on a 2,000 calorie diet.

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.

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, LLC
Nashville, TN 37217
1-855-255-6076

Made in USA

Rev. 06/2018

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

VIRTUS®
PHARMACEUTICALS OPCO II

76439-353-10

Virt-Gard

Prescription Folic Acid-Containing
Dietary Supplement

Rx
100 Tablets
Made in USA

INGREDIENTS AND APPEARANCE

VIRT-GARD 
pyridoxine hydrochloride, folic acid, and cyanocobalamin tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:76439-353
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	2.2 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	1 mg

Inactive Ingredients
Ingredient Name	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYDEXTROSE (UNII: VH2XOU12IE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:76439-353-10	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		09/30/2015

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
size (solid drugs)	10 mm
shape
scoring	1
imprint

Labeler - Virtus Pharmaceuticals (079659493)