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)-OB. Allergic reactions have been reported with some forms of Gum Acacia to include respiratory problems and skin lesions.

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)-OB 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:VITAMINS AND MINERALS:Vitamin (as beta carotene)2700IUVitamin (as ascorbic acid)70mgVitamin D3 (as cholecalciferol)400IUVitamin (as dl-alpha tocopheryl acetate)30IUThiamine mononitrate (Vitamin B1)1.6mgRiboflavin (Vitamin B2)1.8mgNiacin (as niacinamide)18mgVitamin B6 (as pyridoxine hydrochloride)2.5mgFolic acid1.0mgVitamin B12 (as cyanocobalamin)12mcgCalcium (as calcium carbonate)100mgIron (as ferrous fumarate)65mgMagnesium (as magnesium oxide)25mgZinc (as zinc oxide)25mgCopper (as copper oxide)2mgOther Ingredients: Microcrystalline Cellulose, Gelatin, Sodium Croscarmellose, Stearic Acid, Gum Acacia, Silicon Dioxide, Magnesium Stearate, Modified Food Starch, Sucrose, Silicon Dioxide, Maize Starch, Dicalcium Phosphate, Sodium Ascorbate, Tocopherol Concentrate, Medium Chain Triglycerides, Sorbic Acid, Tricalcium Phosphate, dl-Alpha-Tocopherol. Coating: Hypromellose, Titanium Dioxide, Polydextrose, Triacetin, Hydroxypropyl Cellulose, FD&C Blue / Aluminum Lake, Polyethylene Glycol, FD&C Blue / Aluminum Lake, FD&C Yellow 10 Aluminum Lake. Contains: Soy.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Before, during and after pregnancy, one caplet 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.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.Zinc can inhibit the absorption of certain antibiotics; take at least hours apart to minimize interactions.Consult appropriate references for additional specific vitamin-drug interactions.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Vitafol(R)-OB is available as light blue caplet, debossed EV0079. Available in Box of Unit-Dose pack of 100 (NDC 0642-0079-12) and as professional samples (0642-0079-03).. Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat and moisture.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Vitafol(R)-OB is indicated to provide vitamin, 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 100 Caplet Carton. 0642-0079-12Vitafol(R)-OBPrenatal Supplement10 10 UNIT DOSE PACK 100 CAPLETS Rx PRINCIPAL DISPLAY PANEL 100 Caplet Carton.

PEDIATRIC USE SECTION.

Pediatric Use. Not for pediatric use.

PRECAUTIONS 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.Zinc can inhibit the absorption of certain antibiotics; take at least hours apart to minimize interactions.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 and moisture.

WARNINGS 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.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.