VITAFOL NANO- cholecalciferol, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, iron, and iodine tabl

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204), IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7), IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)

Available from:

Exeltis USA, Inc.

INN (International Name):

CHOLECALCIFEROL

Composition:

CHOLECALCIFEROL 1000 [iU]

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vitafol ® -Nano is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).

Product summary:

Vitafol ® -Nano is available as a light blue, round tablet imprinted with "94" on one side. Available in 30 cts in HDPE bottle, 0642-0094-01. Store at room temperature approximately 20°-25°C (68°-77°F). Avoid excessive heat, light, moisture and humidity.

Authorization status:

unapproved drug other

Summary of Product characteristics

VITAFOL NANO- CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID,
LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE TABLET, COATED
EXELTIS USA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
VITAFOL
-NANO
PRECONCEPTION AND PRENATAL SUPPLEMENT
COMPOSITION
Amount per Tablet:
VITAMINS AND MINERALS
Vitamin D (as cholecalciferol)
25 mcg
Vitamin B6 (as pyridoxine
hydrochloride)
2.5 mg
Folate
(as Folic acid USP 680 mcg DFE and
L-methylfolate calcium 1020 mcg
DFE, as Metafolin
CAS# 151533-
22-1)
1700 mcg DFE
Vitamin B12 (as cyanocobalamin)
12 mcg
Iron (as ferrous fumarate)
18 mg
Iodine (as potassium iodide)
150 mcg
OTHER INGREDIENTS
Microcrystalline cellulose, hydroxypropylcellulose, modified food
starch, croscarmellose
sodium, magnesium stearate, sucrose, silicon dioxide, dibasic calcium
phosphate,
polyvinyl alcohol, titanium dioxide (as color), polyethylene glycol,
talc, sodium ascorbate,
medium chain triglycerides, dl-alpha-tocopherol, sucralose, FD&C Blue
#2 Aluminum
Lake.
USAGE
Vitafol
-Nano provides vitamin and mineral supplementation prior to
conception,
throughout pregnancy, and during the postnatal period for the
lactating and non-
lactating mother.
CONTRAINDICATIONS
Vitafol
-Nano is contraindicated in patients with hypersensitivity to any of
its
®
®
®
®
components or color additives.
Folic acid is contraindicated in patients with untreated and
uncomplicated pernicious
anemia, and in those with anaphylactic sensitivity to folic acid.
Iron therapy is contraindicated in patients with hemochromatosis and
patients with iron
storage disease or the potential for iron storage disease due to
chronic hemolytic
anemia (e.g., inherited anomalies of hemoglobin structure or synthesis
and/or red cell
enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis
of the liver.
Cyanocobalamin is contraindicated in patients with sensitivity to
cobalt or t