VIRT-VITE FORTE- pyridoxine hydrochloride, folic acid, and cyanocobalamin tablet, coated

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 HYDROCHLORIDE 25 mg

Administration route:

ORAL

Therapeutic indications:

This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated. Virt-Vite Forte Tablets is indicated for patients in need of dietary supplementation as determined by a licensed medical practitioner. Virt-Vite Forte Tablets should be administered under the supervision of a licensed medical practitioner

Product summary:

Virt-Vite Forte Tablets are round coated beige tablets debossed on one side with "V201", and are supplied in bottles of 90 tablets.

Authorization status:

Dietary Supplement

Summary of Product characteristics

VIRT-VITE FORTE- PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, AND
CYANOCOBALAMIN TABLET, COATED
VIRTUS PHARMACEUTICALS
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VIRT-VITE FORTE TABLETS
PRESCRIPTION DIETARY SUPPLEMENT
RX
DESCRIPTION
Virt-Vite Forte Tablets is an orally administered prescription dietary
supplement specifically
formulated for the dietary management of patients with unique
nutritional needs requiring increased
folate levels.
Virt-Vite Forte Tablets should be administered under the supervision
of a licensed medical practitioner.
Each round coated beige tablet contains the following dietary
ingredients:
SUPPLEMENT FACT S
SERVING SIZE: 1 TABLET
AMOUNT
PER
SERVING
% DAILY
VALUE
_**Daily Values not established for patients with unique_
_nutritional needs who are in need of supplementation as directed_
_by a licensed medical practitioner._
VITAMIN B (as Pyridoxine HCl)
25 mg
1250%
FOLACIN (Vitamin B )
2.5 mg
625%
VITAMIN B
(as Cyanocobalamin)
2 mg
33333%
OTHER INGREDIENTS: Dibasic Calcium Phosphate Dihydrate,
Microcrystalline Cellulose Ph 101, Opadry
II Beige 40L17427 (Titanium Dioxide, Polydextrose, HPMC
2910/Hypromellose 3 cP, HPMC
2910/Hypromellose 6 cP, Triacetin/Glycerol Tri-acetate, HPMC
2910/Hypromellose 50 cP,
Macrogol/Peg 8000, FD&C Yellow #6/Sunset Yellow Aluminum Lake, FD&C
Blue #2/Indigo Carmine
Aluminum Lake, FD&C Red #40/Allura Red Aluminum Lake), Croscarmellose
Sodium, Opadry II Clear
Y-19-7483 (HPMC 2910/Hypromellose 6 cP, Maltodextrin, HPMC
2910/Hypromellose 3 cP,
Macrogol/Peg 400, HPMC 2910/Hypromellose 50 cP, Magnesium Stearate
FOLATE MECHANISM OF ACTION
FOLATE is essential for the production of certain coenzymes in many
metabolic systems such as purine
and pyrimidine synthesis. It is also essential in the synthesis and
maintenance of nucleoprotein in
erythropoiesis. It also promotes white blood cell (WBC) and platelet
production in folate-deficiency
anemia. Folate is associated with methylation and transformylation
biochemistry.
FOLATE REGULATION
The Federal Register Notices from 1971 to 1973 established that
increased fola