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Boxed warning
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.
Uses described in the label
INDICATIONS: Niferex® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
Dosage and administration — label text
DOSAGE AND ADMINISTRATION: One tablet daily, or as directed by a physician.
Contraindications
CONTRAINDICATIONS : Niferex® is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Adverse reactions
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Unclassified section
Rx Only Dietary Supplement
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. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 1-888-61-AVION L-0437 Rev. 0924-01 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.
Product description
DESCRIPTION: Niferex® for oral administration is an iron supplement that is an oval, copper colored, coated tablet with "344" embossed on one side. table
Inactive ingredient
OTHER INGREDIENTS: Discalcium phosphate dihydrate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, magnesium stearate. Coating contains: Candurin® 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.
Precautions
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.
Supply and packaging
HOW SUPPLIED: Bottles of 30 tablets (75854-344-30). 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 and handling
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.