HOW SUPPLIED SECTION.
HOW SUPPLIED. Bottles of 30 Tablets (85477-901-30). Tablet is tan, oblong.
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INDICATIONS & USAGE SECTION.
INDICATIONS AND USAGE. Folarex is prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin supplementation, and maintenance of good health is needed.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL. 85477-511-30FolarexMULTIVITAMIN30 TABLETSOncora Pharma, LLC. 85477-511-30FolarexMULTIVITAMIN30 TABLETS.
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PRECAUTIONS SECTION.
PRECAUTIONS. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin 12 deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
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STORAGE AND HANDLING SECTION.
STORAGE. STORAGE: Store at 20- 25 degree (68-77 F) excersions permitted to 15-30 degree (59-86 F) See USP contro led Room Temperature Avoid excessive heat, light and moisture.TAMPER EVIDENT: Do not use if seal is broken or missing. MADE IN USADistributed by:888-321-2821Oncora Pharma Da las, TX 75161.
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WARNINGS SECTION.
WARNINGS. WARNING Accidental overdose of iron-containing products is leading cause of fatal poising in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In the case of accidental overdose, ca a doctor or poison control center immediately.
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ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS. Allergic sensitization has been reported fo lowing both oral and parenteral administration of folic acid. You should ca your doctor for medical advice about serious adverse events. To reports adverse side effects or to obtain product information, contact Oncora Pharma at 888-321-2821.
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CONTRAINDICATIONS SECTION.
CONTRAINDICATIONS. Folarex is contraindicated in patients with known hypersensitivity to any of the ingredients.
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DESCRIPTION SECTION.
DESCRIPTION. Folarex is prescription multivitamin/multimineral dietary supplement.SUPPLEMENT FACTSServingsizeAmount per serving:1tablet% Daily Value Vitamin (as Beta-Carotene)300 mcg RAE33%Vitamin (as Ascorbic Acid)60mg67%Vitamin (as Cholecalciferol)10mcg50%Vitamin (as di-Alpha Tocopherol Acetate)4.5 mg (10 IU)33%Vitamin 86 (as Pyrldoxine HCI)26mg1529%Biotin0.280mg933%Folate1.67 mg DFE418%(from Folic Acid)0.67 mg DFE(from Methyl Tetrahydrotolate Calcium Salt)1 mg DFEVitamin 812 (as Cyanocobalamin)0.013 mg542%Calcium (as Calcium Carbonate)80 mg6%Magnesium (as Magnesium Oxide)25mg6%Ferrochel20mg111mgIodine (as Potassium Iodide)0.150mg100%Other Ingredients: Microcrysta line Ce lulose, Maltodextrin, Croscarme lose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylce lulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue 1.
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DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. One tablet daily or as directed by physician.
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