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).

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 the reach of children. In case of accidental overdose, call doctor or Poison Control Center immediately.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Vitafol(R) 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 B-12).

DESCRIPTION SECTION.

COMPOSITION. Each caplet contains:Vitamin (as acetate)6000 IUVitamin (as ascorbic acid)60 mgVitamin D-3 (as cholecalciferol)400 IUVitamin (as d-alpha tocopheryl acetate)30 IUThiamine Mononitrate1.1 mgVitamin B-2 (as riboflavin)1.8 mgNiacinamide (Vitamin B-3)15 mgPyridoxine HCl2.5 mgFolic Acid1 .0 mgVitamin B-12 (as cyanocobalamin)5 mcgCalcium (as calcium carbonate)125 mgIron (as ferrous fumarate)65 mgOther Ingredients: Microcrystalline Cellulose, Stearic Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, Silica, Acacia, Maltodextrin, Hypromellose, Citric Acid, Soy Polysaccharide, Sodium Lauryl Sulfate, Magnesium Stearate, Titanium Dioxide, Magnesium Silicate, Gum Arabic, Polyethylene Glycol, Mineral Oil, Polyvinylpyrrolidone, FD&C Red 40 Lake, D&C Red 27 Lake and FD&C Blue Lake. Contains Soy.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. One caplet daily, preferably after meal or as prescribed by physician.

DRUG INTERACTIONS SECTION.

Drug Interactions. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.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) is available as pink, capsule shaped caplet, debossed EV0072. Available in box of unit dose pack of 100 (0642-0072-12).. Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat, moisture and protect from light.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Vitafol(R) is indicated to provide vitamin, mineral supplementation to support optimum vitamin levels.

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 100 Caplet Carton. 0642-0072-12VITAFOL(R) Multivitamin Supplement10 10 UNIT DOSE PACK100 CAPLETSRx PRINCIPAL DISPLAY PANEL 100 Caplet Carton.

PEDIATRIC USE SECTION.

Pediatric Use. Not for pediatric use.

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

STORAGE AND HANDLING SECTION.

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