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: FeRiva FA (R) is contraindicated in patients with known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.

DESCRIPTION SECTION.

DESCRIPTION: FeRiva FA (R) is prescription iron supplement. FeRiva FA (R) is red gel capsule. Facts.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION: Adults, one (1) capsule daily, with or without food, or asprescribed by your healthcare provider. Do not administer to children under the age of 12.

HOW SUPPLIED SECTION.

HOW SUPPLIED: In child-resistant bottles of 30 capsules (75854-319-30). The listed product number is not National Drug Code, but has instead been formatted to comply with standard industry practice for pharmacy computer systems.

INACTIVE INGREDIENT SECTION.

OTHER INGREDIENTS: Silicon dioxide and magnesium stearate. Gel capsule: (bovine gelatin,titanium dioxide, FD&C blue and FD&C red 40).

INDICATIONS & USAGE SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. 75854-0319-30FeRivaFA (TM) Iron Supplement30 CapsulesRx OnlyAvion PHARMACEUTICALS fa.

PEDIATRIC USE SECTION.

PEDIATRIC USE: Safety and effectiveness have not been studied in pediatric patients.

PRECAUTIONS SECTION.

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and othermegaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologicremission can occur while neurological manifestations progress. While prescribing this nutritional supplement for pregnant women, nursingmothers or for women prior to conception, their medical condition and other drugs, herbs and/or supplements consumption should be considered.

SPL UNCLASSIFIED SECTION.

Iron SupplementRx 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.].