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FERREX 150 FORTE PLUS
folic acid and
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----------Ferrex ™ 150 Forte Plus
Each Ferrex™ 150 Forte Plus Capsule contains:
Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, FD&C Blue No.1 Lake, FD&C Red No.40 Lake, Gelatin, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Stearic Acid and Titanium Dioxide.
INDICATIONS AND USAGE
Ferrex 150™ Forte Plus is indicated for the dietary management of iron deficiencies and/or nutritional megaloblastic anemias.
Ferrex™ 150 Forte Plus is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to the use of this product.
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.
Do not exceed recommended dose.
The type of anemia and the underlying cause or causes should be determined before starting with Ferrex™ 150 Forte Plus. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.
Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.
Clinical studies on this product have not been performed in 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. Adverse reactions with iron therapy are usually transient.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
Ferrex™ 150 Forte Plus capsules are available as a white/red capsule, imprinted B 798. Supplied in bottles of 90 capsules, NDC 51991-798-90.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
*U.S. Patent Nos. 5,516,925; 6,716,814
PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label
Revised: 03/2011 Breckenridge Pharmaceutical, Inc.
Reproduced with permission of U.S. National Library of Medicine
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