INACTIVE INGREDIENT SECTION.
OTHER INGREDIENTS: Dicalcium phosphate, microcrystalline cellulose, croscarmelose sodium, vegetable stearate, silicon dioxide.
CONTRAINDICATIONS: Niferex is contraindicated in patients with a known hypersensitivity to any of the ingredients.
SPL UNCLASSIFIED SECTION.
Quatrefolic is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent #7,947,662 CAS #1181972-37-1 Sumalate is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 6,716,814, 8,007,846 and 8,425,956. MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30022 1-888-61-AVION Rev. 1016-05 AV-428 THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOTINTENDED TO DIAGNOSE, TREAT, CURE OR INTENDED TO DIAGNOSE, PREVENT ANY DISEASE.
DESCRIPTION: Niferex for oral administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with NxFE embossed on one side. Supplement Facts Serving Size: 1 tablet Amount per Serving: % Daily Value Iron (as Sumalate (ferrous asparto glycinate 50 mg) 150 mg and polysaccharide iron complex 100 mg) 150 mg 833% Vitamin C (as ascorbic acid) 60 mg 100% Folate (as 1.4 mg Quatrefolic ((6S)-5, methyltetrahydrofolate glucosamine salt molar equivalent to 750 mcg of folic acid) and folic acid, USP 250 mcg) 1 mg 250% Vitamin B12 (as cyanocobalamin) 25 mcg 417% Zinc (as zinc-bisglycinate chelate 15 mg 100% Succinic Acid 50 mg Desiccated Stomach Substance 100 mg Daily Value (DV) not established
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
STORAGE AND HANDLING SECTION.
STORAGE: Store at 20 - 25C (68 - 77F); excursions permitted to 15 - 30C (59 - 86F) [See USP Controlled Room Temperature.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
BOXED WARNING SECTION.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Rx Only Dietary Supplement 75854-321-30 30 Tablets Sugar Free Lactose Free NiferexTM www.niferexrx.com tablets
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
INDICATIONS & USAGE SECTION.
INDICATIONS: Niferex is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.
HOW SUPPLIED SECTION.
HOW SUPPLIED: Bottles of 30 tablets (75854-321-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.