NIVA-FOL- pyridoxine, 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:

Nivagen Pharmaceuticals, Inc.

INN (International Name):

Pyridoxine Hydrochloride

Composition:

Pyridoxine Hydrochloride 25 mg

Administration route:

ORAL

Therapeutic indications:

For the dietary management of individuals with distinct nutritional needs under a physician or health-care provider's supervision for hyperhomocysteinemia; with particular emphasis for individuals with or at risk for atherosclerotic vascular disease in the coronary1 , peripheral2 , or cerebral3 vessels, or vitamin B12 deficiency4 . Niva-Fol™ Tablets are labeled as a medical food intended for use under active and ongoing medical supervision requiring medical care on a recurring basis for, among other things, instructions on the use of the medical food. Known hypersensitivity to any of the components in the product is a contraindication.

Product summary:

Niva-Fol™ Tablets are available as an oval, coated tablet, debossed "N080". Supplied in bottles of 90 Tablets, 75834-080-90 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Authorization status:

Dietary Supplement

Summary of Product characteristics

NIVA-FOL- PYRIDOXINE, FOLIC ACID, AND CYANOCOBALAMIN TABLET
NIVAGEN PHARMACEUTICALS, INC.
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NIVA-FOL™ TABLETS
Medical Food
EACH NIVA-FOL™ TABLET CONTAINS:
Vitamin B (as
Pyridoxine HCl)
25 mg
Folacin (Folic Acid)
2.5 mg
Vitamin B
(as
Cyanocobalamin)
2 mg
Other Ingredients:
Carmine, Calcium Carbonate, Magnesium Stearate, Stearic Acid, Starch,
Croscarmellose
Sodium, Silicon Dioxide, and Shellac. Contains no sugar, salt, yeast,
milk, egg, shellfish,
preservatives, artificial flavors or color.
INDICATIONS AND USAGE
For the dietary management of individuals with distinct nutritional
needs under a
physician or health-care provider's supervision for
hyperhomocysteinemia; with
particular emphasis for individuals with or at risk for
atherosclerotic vascular disease in
the coronary , peripheral
, or cerebral
vessels, or vitamin B
deficiency . Niva-Fol™
Tablets are labeled as a medical food intended for use under active
and ongoing medical
supervision requiring medical care on a recurring basis for, among
other things,
instructions on the use of the medical food.
MEDICAL FOODS
Medical foods are Intended for the dietary management of a patient
who, because of
therapeutic or chronic medical needs, has limited or impaired capacity
to ingest, digest,
absorb, or metabolize ordinary foodstuffs or certain nutrients, or who
has other special
medically determined nutrient requirements, the dietary management of
which cannot
be achieved by the modification of a normal diet alone. Although a
medical-food product
is intended for use under the active and ongoing medical supervision,
FDA does not
require a prescription.
These statements have not been evaluated by the Food and Drug
Administration. This
product is not intended to diagnose, treat, cure or prevent any
disease.
PRECAUTIONS
Folacin (folic acid) when administered as a single agent in doses
above 0.1 mg daily, may
6
12
1
2
3
12
4
obscure pernicious anemia in that hematologic remission can occur
while neurological
manifestations remain progressive. The 2 mg of cyano