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ascorbic acid and
docusate sodium tablet
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----------RE Iron Tablets 90 mg
INDICATIONS AND USAGE
RE Iron Tablets 90mg is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.
RE Iron Tablets 90mg is contraindicated in patients with known hypersensitivity to any of its ingredients. Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron stage disease dude to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.) pyridoxine responsive anemia or cirrhosis of the liver.
WARNINGS AND PRECAUTIONSAccidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
General: Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with RE Iron Tablets 90mg. 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: Folic acid in doses above 1.0 mg daily may obscure pernicious anemia.
Allergic sensitivity reactions and gastrointestinal disturbances may occur with iron therapy. Folic Acid allergic sensitization has been reported following both oral and parenteral administration.
There is a variety of iron/drug interactions which include antacids, tetracyclines, or fluoroquinolones.
USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
The clinical course of acute iron overdosage can vary. 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.
DESCRIPTIONEach reddish-brown, film-coated tablet for oral administration contains:
Iron (Carbonyl Iron) 90 mg
Folic Acid 1 mg
Vitamin B12 (Cyanocobalamin) 12 mcg
Vitamin C (Ascorbic acid) 120 mg
Docusate sodium 50 mg
Inactive ingredients: Sodium Benzoate, Silicon Dioxide, Microcrystalline Cellulose, Stearic Acid, Croscarmellose Sodium, Dicalcium Phosphate Dihydrate, Talc, FD&C Yellow No.6, FD&C Red No.40, FD&C Blue No.2, and Macrogol.
Iron is necessary for the proper functioning of hemoglobin and red blood cell production.
Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the hematological profile or pernicious anemia, it does not ameliorate the underlying neurologic involvement.
HOW SUPPLIED/STORAGE AND HANDLING
RE Iron Tablets 90 mg (NDC 68032-371-90) is a reddish-brown, modified rectangle shaped, film-coated tablet, debossed with “RE 371” on one side and blank on the other, and packaged in bottles of 90.
Revised: 12/2010 River's Edge Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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