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 REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.
CONTRAINDICATIONS: Niferex(TM) is contraindicated in patients with known hypersensitivity to any of the ingredients.
DESCRIPTION: Niferex(TM) for oral administrationis prenatal/postnatal iron supplement that is round, copper colored tablet with NxFE embossed on one side. table.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by physician.
HOW SUPPLIED SECTION.
HOW SUPPLIED: Bottles of 30 tablets (75854-321-30). The listed product number is not National Drug Code. Instead, Avion Pharmaceuticals has assigned product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
INACTIVE INGREDIENT SECTION.
OTHER INGREDIENTS: Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Coating contains: HPMC, triacetin, titanium dioxide, Candurin(R) Orange (FD&C Blue 1, FD&C Red 40, FD&C Yellow 6). This product contains FD&C Yellow 6.
INDICATIONS & USAGE SECTION.
INDICATIONS: Niferex(TM) is multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Rx Only Dietary Supplement 75854-321-3030 Tablets Sugar Free Lactose FreeNiferex TM www.niferexrx.com tablets. Ni.
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.
SPL UNCLASSIFIED SECTION.
Rx Only Dietary Supplement.
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.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.