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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Available from:

Virtus Pharmaceuticals

INN (International Name):

Pyridoxine Hydrochloride

Composition:

Pyridoxine 25 mg

Administration route:

ORAL

Therapeutic indications:

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. This product is contraindicated in people with known history of hypersensitivity to any of the ingredients. Safety and effectiveness in pediatric patients have not been established.

Product summary:

Supplied as round, pink tablets imprinted with "V353," dispensed in bottles of 100 tablets. 76439-353-10

Authorization status:

Dietary Supplement

Summary of Product characteristics

VIRT-GARD- PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, AND CYANOCOBALAMIN
TABLET
VIRTUS PHARMACEUTICALS
----------
VIRT-GARD
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 B
(Pyridoxine HCl)
25 mg
1471%
FOLATE
(2200 mcg Folic Acid)
3667 mcg DFE
917%
VITAMIN B
(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.
6
12
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,