ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS. Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call 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. Folaten is contraindicated in patients with known hypersensitivity to any of the ingredients.
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DESCRIPTION SECTION.
DESCRIPTION. Folaten 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 FE418%(from Folic Acid)0.67 mg FE(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: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylcellulose, 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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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. Folaten is prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of subuoptimal nutritional status in patients where advanced folate, vitamin supplementa-tion, and maintenance of good health is needed.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL. label.
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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 controlled Room Temperature Avoid excessive heat, light and moisture.TAMPER EVIDENT: Do not use if seal is broken or missing.MADE IN USA Distributed by: 888-321-2821 Oncora Pharma Dallas, TX 75161.
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WARNINGS SECTION.
WARNINGS. WARNINGAccidental 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, call doctor or poison control center immediately.
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