ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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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.
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CONTRAINDICATIONS SECTION.
CONTRAINDICATIONS. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
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DESCRIPTION SECTION.
DESCRIPTION. NataFort(R) is prescription prenatal/postnatal multivitamin/mineral supplement. The tablet is white, coated, and oval in shape, and is debossed N1 on one side and is blank on the other.. Each prenatal tablet contains:Vitamin (Ascorbic acid)120 mgVitamin D3 (Cholecalciferol)400 IUVitamin (dl-alpha tocoperyl acetate) 11 IUThiamin (Vitamin B1) mgRiboflavin (Vitamin B2) mgNiacinamide (Vitamin B3) 20 mgVitamin B6 (Pyridoxine HCl) 10 mgFolic Acid mgVitamin B12 (Cyanocobalamin) 12 mcgIron (Ferrous fumarate, carbonyl iron) 60 mg.
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DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. One tablet daily or as directed by physician.
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HOW SUPPLIED SECTION.
HOW SUPPLIED. Bottles of 90 tablets each NDC 0178-0716-90.
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INDICATIONS & USAGE SECTION.
INDICATIONS. NataFort(R) is multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL 90 Tablet Bottle Label. NDC 0178-0716-90NataFort(R) PRENATAL MULTIVITAMIN TABLET WITH IRONFor use before, during and after pregnancy90 TabletsRx OnlyMission(R) PHARMACALUS Patent 6,521,247. PRINCIPAL DISPLAY PANEL 90 Tablet Bottle Label.
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PRECAUTIONS SECTION.
PRECAUTIONS. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
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SPL UNCLASSIFIED SECTION.
Each prenatal tablet contains:Vitamin (Ascorbic acid)120 mgVitamin D3 (Cholecalciferol)400 IUVitamin (dl-alpha tocoperyl acetate) 11 IUThiamin (Vitamin B1) mgRiboflavin (Vitamin B2) mgNiacinamide (Vitamin B3) 20 mgVitamin B6 (Pyridoxine HCl) 10 mgFolic Acid mgVitamin B12 (Cyanocobalamin) 12 mcgIron (Ferrous fumarate, carbonyl iron) 60 mg.
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STORAGE AND HANDLING SECTION.
Store at controlled room temperature.NOTICE: Contact with moisture can discolor or erode the tablet.
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WARNINGS SECTION.
WARNING. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
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