FOLVITE-D- folic acid and cholecalciferol tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)

Available from:

NEOMED PHARMACEUTICAL

Administration route:

ORAL

Therapeutic indications:

FOLVITE-D  tablet is an orally administered prescription strength folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D levels, or used in improving the nutritional status of patients with folic acid and vitamin D deficiency. FOLVITE-D  should be administered under the supervision of a licensed medical practitioner. Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water. Folic acid occurs as a yellow or yellowishorange crystalline powder and is very soluble in water and insoluble in alcohol. The structural formula of Vitamin D3 and folic acid are as follows: Each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide, Stearic acid, HPMC E15, HPMC E5/E6, PEG 8000. INDICATIONS AND USAGE FOLVITE-D  is indicated for dietary management of patients with unique nutritional needs requiring increased folate level

Product summary:

FOLVITE-D  tablets are dispensed in bottles of 90ct  (70898-409-09) FOLVITE-D  tablets are clear coated and caplet shaped tablets All prescriptions using this product shall be pursuant to state statutes as applicable. This product is an Rx only and may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence. STORAGE KEEP OUT OF THE REACH OF CHILDREN Store at 20°-25°C (66°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture. Manufactured for: Neomed Pharmaceutical Brentwood, NY 11717

Authorization status:

Dietary Supplement

Summary of Product characteristics

FOLVITE-D- FOLIC ACID AND CHOLECALCIFEROL TABLET, COATED
NEOMED PHARMACEUTICAL
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FOLVITE-D
DESCRIPTION
FOLVITE-D tablet is an orally administered prescription strength
folate product for the dietary
management of patients with unique nutritional needs requiring
increased folate levels, Vitamin D
levels, or used in improving the nutritional status of patients with
folic acid and vitamin D deficiency.
FOLVITE-D should be administered under the supervision of a licensed
medical practitioner. Vitamin
D3 (cholecalciferol) is a white, crystalline powder, very soluble in
water. Folic acid occurs as a
yellow or yellowishorange crystalline powder and is very soluble in
water and insoluble in alcohol.
The structural formula of Vitamin D3 and folic acid are as follows:
EACH TABLET CONTAINS:
Folic Acid
1000 MCG
Vitamin D3 (Cholecalciferol)
94.375
MCG
Each tablet contains the following inactive ingredients:
Microcrystalline Cellulose, Dicalcium
Phosphate, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide,
Stearic acid, HPMC E15,
HPMC E5/E6, PEG 8000.
INDICATIONS AND USAGE
FOLVITE-D is indicated for dietary management of patients with unique
nutritional needs requiring
increased folate levels, Vitamin D levels, or used in improving the
nutritional status of patients with
folic acid and vitamin D deficiency.
DOSAGE:
Usual adult dose is 1 tablet once or twice daily or as prescribed by a
licensed medical practitioner.
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This statement has not been evaluated by the FDA. This product is not
intended to diagnose, treat, cure,
or prevent disease.
CLINICAL PHARMACOLOGY
The_ in vivo_ synthesis of the major biologically active metabolites
of vitamin D occurs in two steps. The
first hydroxylation of Vitamin D takes place in the liver (to
25-hydroxyvitamin D) and the second in the
kidneys (to 1, 25-dihydroxyvitamin D). Vitamin D metabolites promote
the active absorption of calcium
and