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Vitafol Nano

Generic name: cholecalciferol, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, iron and iodine
Dosage form: tablet, coated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

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 to cyanocobalamin (vitamin B12).

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

WARNINGS/PRECAUTIONS

Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.

Prolonged use of iron salts may produce iron storage disease.

Folate, especially in doses above 1700 mcg DFE (1000 mcg folic acid) daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.

Avoid Overdosage. Keep out of the reach of children.

DRUG INTERACTIONS

High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease a patient's response to methotrexate.

Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Consult appropriate references for additional specific vitamin-drug interactions.

Information for Patients

Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

Pediatric Use

Not for pediatric use.

Adverse Reactions

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol®-Nano. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

DIRECTIONS FOR USE

Before, during and after pregnancy, one tablet daily, or as directed by a physician.

How is Vitafol Nano Supplied

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.

Rx

Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349

www.exeltisusa.com
©2021 Exeltis USA, Inc.

Metafolin® is a trademark of Merck KGaA, Darmstadt, Germany

U.S. Patent No. 6,441,168B1; 5,997,915; 6,254,904; 6,808,725; 7,172,778 and 7,674,490

Rev. January 2021
0940101-01

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

0642-0094-01

VITAFOL
Nano

Smallest Prenatal Supplement with essential nutrients

30 Tablets

Rx
DIETARY SUPPLEMENT

VITAFOL NANO
cholecalciferol, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, iron, and iodine tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0642-0094
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLECALCIFEROL (Cholecalciferol) CHOLECALCIFEROL 25 ug
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 2.5 mg
Folic Acid (Folic Acid) Folic Acid 680 ug
Levomefolate Calcium (Levomefolic Acid) Levomefolate Calcium 1020 ug
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Iron (Iron) Iron 18 mg
Iodine (Iodine) Iodine 150 ug
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SUCROSE
SILICON DIOXIDE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
SODIUM ASCORBATE
MEDIUM-CHAIN TRIGLYCERIDES
.ALPHA.-TOCOPHEROL, DL-
SUCRALOSE
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code EV0094
Contains
Packaging
# Item Code Package Description
1 NDC:0642-0094-01 30 TABLET, COATED in 1 BOTTLE
2 NDC:0642-0094-03 3 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 07/14/2014
Labeler - Exeltis USA, Inc. (071170534)
Exeltis USA, Inc.