Iferex 150 Forte

Nnodum Pharmaceuticals

FULL PRESCRIBING INFORMATION

Polysaccharide Iron Complex

Hematinic Capsules

NDC 63044-0198-01

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this products out of the reach of children. In case of accidental overdose, call a doctor or poison control immediately.

Rx Only

IFEREX ^™ 150 Forte Capsules are a highly water soluble complex of iron/low molecular weight polysaccharide and vitamins.

For treatment of iron deficiency anemia and/or nutritional megaloblastic anemias due to inadequate diet.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin 812 is deficient. Keep out of the reach of children. Close tightly and keep out of reach of children. Contains iron, which can be harmful or fatal to children in large doses.

Folic acid in doses above 0..1 mg - 0..4 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use Safety and effectiveness in pediatric patients has not been established.

Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Adults: One capsule daily or as directed by a physician.

Each capsule contains:
Iron (Elemental)    150 mg
(as polysaccharide-iron complex)
Folic Acid     1 mg
Vitamin 812        25 mc

OTHER INGREDIENTS: Microcrystalline Cellulose,Gelatin,Magnesium Strearate, D&C Red #28, Titanium Dioxide, FD&C red #3, D&C Yellow #10, and FD&C Blue # 1

IFEREX ^™ 150 Forte Capsules are Opaque maroon cap/opaque maroon NDC 63044-0198-01.

Supplied in 100 count bottle.

STORAGE: Store at controlled 20°C - 25°C (68°-77°F); excursions permitted to 15°C-30°C (59°- 86°F).

Manufactured for
Nnodum Pharmaceuticals
Cincinnati, Ohio 45229