Generic Name: iron supplement
Dosage Form: tablet
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
DESCRIPTION: Niferex for oral administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with NxFE embossed on one side.
Serving Size: 1 tablet
Amount per Serving:
Iron (as Sumalate® (ferrous asparto glycinate 50 mg) 150 mg
and polysaccharide iron complex 100 mg)
|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)
|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|
OTHER INGREDIENTS: Dicalcium phosphate, microcrystalline cellulose, croscarmelose sodium, vegetable stearate, silicon dioxide.
Niferex™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
CONTRAINDICATIONS: Niferex™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
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.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.
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.
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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.
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 NOT INTENDED TO DIAGNOSE, TREAT, CURE OR INTENDED TO DIAGNOSE, PREVENT ANY DISEASE.
Rx Only Dietary Supplement 75854-321-30
30 Tablets Sugar Free
ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor tablet
|Labeler - Avion Pharmaceuticals, LLC (965450542)|
|Registrant - Avion Pharmaceuticals, LLC (965450542)|
|Avion Pharmaceuticals, LLC||965450542||manufacture(75854-321)|