ADVERSE REACTIONS SECTION.

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

BOXED WARNING SECTION.

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

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Vitafol(R)-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).

DESCRIPTION SECTION.

COMPOSITION. Amount per Tablet:. VITAMINS AND MINERALS. Vitamin (as cholecalciferol)25 mcgVitamin B6 (as pyridoxine hydrochloride)2.5 mgFolate (as Folic acid USP 680 mcg DFE and L-methylfolate calcium 1020 mcg DFE, as Metafolin(R) CAS 151533-22-1)1700 mcg DFEVitamin B12 (as cyanocobalamin)12 mcgIron (as ferrous fumarate)18 mgIodine (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 Aluminum Lake.

DOSAGE & ADMINISTRATION SECTION.

DIRECTIONS FOR USE. Before, during and after pregnancy, one tablet daily, or as directed by physician.

DRUG INTERACTIONS SECTION.

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 patients response to methotrexate.Vitamin 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Vitafol(R)-Nano is available as 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 20-25C (68-77F). Avoid excessive heat, light, moisture and humidity.

INDICATIONS & USAGE SECTION.

USAGE. Vitafol(R)-Nano provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.

INFORMATION FOR PATIENTS SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 30 Tablet Bottle Label. 0642-0094-01VITAFOLNanoSmallest Prenatal Supplement with essential nutrients30 TabletsRx DIETARY SUPPLEMENT. PRINCIPAL DISPLAY PANEL 30 Tablet Bottle Label.

PEDIATRIC USE SECTION.

Pediatric Use. Not for pediatric use.

SPL UNCLASSIFIED SECTION.

VITAMINS AND MINERALS. Vitamin (as cholecalciferol)25 mcgVitamin B6 (as pyridoxine hydrochloride)2.5 mgFolate (as Folic acid USP 680 mcg DFE and L-methylfolate calcium 1020 mcg DFE, as Metafolin(R) CAS 151533-22-1)1700 mcg DFEVitamin B12 (as cyanocobalamin)12 mcgIron (as ferrous fumarate)18 mgIodine (as potassium iodide)150 mcg.

STORAGE AND HANDLING SECTION.

Store at room temperature approximately 20-25C (68-77F). Avoid excessive heat, light, moisture and humidity.

WARNINGS AND PRECAUTIONS SECTION.

WARNINGS/PRECAUTIONS. Vitamin 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 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 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 patients response to methotrexate.Vitamin 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.