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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. For further information about unapproved drugs, click here.

Vitafol®-Nano
Preconception and Prenatal Supplement

Rx

COMPOSITION

Amount per Tablet:

VITAMINS AND MINERALS:
Vitamin D (as cholecalciferol) 1000 IU
Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg
Folate
(as Folic acid USP 0.4 mg and L-methylfolate calcium 0.6 mg, as Metafolin® CAS# 151533-22-1)
1 mg
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.

Folic acid, especially in doses above 0.1 mg 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 INTERATIONS

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 breastfeeding.

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 Box of Unit-Dose pack of 30 (2 child resistant blister cards of 15 tablets), 0642-0094-30 and as professional samples, 0642-0094-03.

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture.

Rx

Manufactured for
EVERETT LABORATORIES, INC.
Chatham, NJ 07928

You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349

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. 03/14)

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

0642-0094-30

Vitafol® Nano
Preconception and Prenatal Supplement

METAFOLIN®

  • Once daily tablet
  • 1 mg Folate (400 mcg as Folic Acid
    and 600 mcg as Metafolin®
  • 1000 IU Vitamin D
  • Essential nutrients in a
    tolerable form without DHA

ACTUAL SIZE

Rx

Unit Dose Pack/30 Tablets

U.S. PATENTED

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 1000 [iU]
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 2.5 mg
Folic Acid (Folic Acid) Folic Acid 0.4 mg
Levomefolate Calcium (Levomefolic Acid) Levomefolate Calcium 0.6 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Iron (Iron) Iron 18 mg
Iodine (Iodine) Iodine 150 ug
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
HYDROXYPROPYL CELLULOSE (TYPE H)  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
SUCROSE  
SILICON DIOXIDE  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
POLYVINYL ALCOHOL  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOLS  
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:0642-0094-30 30 TABLET, COATED in 1 BLISTER PACK
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 - Everett Laboratories, Inc. (071170534)
Revised: 07/2014
 
Everett Laboratories, Inc.
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