INDICATIONS & USAGE SECTION.

INDICATIONS: Niferex(R) is multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

75854-344-30Rx Only Dietary Supplement30 Tablets Sugar FreeLactose FreeNiferex(R) Tablets (ferrous asparto glycinate)www.niferex.com. Niferex-label.

PRECAUTIONS SECTION.

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.].

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

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 SECTION.

CONTRAINDICATIONS: Niferex(R) is contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.

DESCRIPTION: Niferex(R) for oral administration is an iron supplement that is an oval, copper colored, coated tablet with 344 embossed on one side.. table.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION: One tablet daily, or as directed by physician.

HOW SUPPLIED SECTION.

HOW SUPPLIED: Bottles of 30 tablets (75854-344-30). 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: Discalcium phosphate dihydrate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, magnesium stearate. Coating contains: Candurin(R) Orange (FD&C Blue 1, FD&C Red 40, FD&C Yellow 6), HPMC, titanium dioxide and triacetin.This product contains FD&C Yellow 6.