ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

BOXED WARNING SECTION.

WARNING. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin 12 is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

DESCRIPTION SECTION.

DESCRIPTION. Each green film-coated tablet for oral administration contains:Iron (Carbonyl iron, ferrous gluconate) 90 mgFolic Acid 11 mgVitamin 12 (Cyanocobalamin) 12 mcgVitamin (Ascorbic acid)120 mgDocusate sodium 5050 mgInactive Ingredients: Povidone, croscarmellose sodium, acrylic resin, color added, magnesium stearate, FD&C Yellow No. 5, magnesium silicate, FD&C Blue No. 1, polyethylene glycol, vitamin palmitate, ethyl vanillin.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. One tablet daily or as directed by physician.

GENERAL PRECAUTIONS SECTION.

General. Take hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with Ferralet (R) 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if dose change is indicated. This product contains FD&C Yellow No. (tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

GERIATRIC USE SECTION.

Geriatric Use. Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Ferralet (R) 90 (NDC 0178-0089-90) is green, modified rectangle shaped, film-coated tablet, debossed with F6 on one side and blank on the other, and packaged in bottles of 90. Store at 25C (77F). Excursions permitted to 15-30C (59-86F). (See USP Controlled Room Temperature.).

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Ferralet (R) 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, postsurgical convalescence, and dietary needs.

OVERDOSAGE SECTION.

OVERDOSAGE. Symptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrohosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 90 mg Tablet Bottle Label. NDC 0178-0089-90 Rx OnlyFerralet(R) 90 90 mg Dual-Iron Delivery 90 Coated TabletsMission (R) PHARMACAL PRINCIPAL DISPLAY PANEL 90 mg Tablet Bottle Label.

PEDIATRIC USE SECTION.

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

PRECAUTIONS SECTION.

PRECAUTIONS. General. Take hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with Ferralet (R) 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if dose change is indicated. This product contains FD&C Yellow No. (tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Folic Acid. 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 these products since folic acid may mask the symptoms of pernicious anemia.. Pediatric Use. Safety and effectiveness in pediatric patients have not been established.. Geriatric Use. Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

SPL PATIENT PACKAGE INSERT SECTION.

Ferralet(R) 9090 mg Dual-Iron Delivery RX ONLYTHERAPEUTIC GUIDELINES FOR THE PATIENT Some facts you should know about Iron Deficiency AnemiaIron Deficiency Anemia, or IDA, is common type of anemia. Its condition in which blood lacks an adequate supply of healthy red blood cells. These cells carry oxygen to tissues. It is oxygenated blood that gives your body energy and your skin healthy color.As the name suggests, Iron Deficiency Anemia results from insufficient iron. Your body needs iron to make substance called hemoglobin. Its the hemoglobin in red blood cells that enables them to carry oxygen.What causes IDAThere are many causes of IDA. These include:A diet consistently low in ironBlood loss due to heavy menstrual bleedingPoor iron absorption from food due to intestinal surgery or diseases of the intestinePregnancy (when the need for iron increases significantly)Women in general are at higher risk of IDA, not only because they lose blood during menstruation but also because their bodies store less iron.How common is itIDA is common nutritional deficiency, with women most widely affected. Up to 20% of women have IDA.What are the symptomsSome of the symptoms most commonly associated with IDA are fatigue, weakness, and headache. Symptoms may also include light-headedness, pale skin, shortness of breath, and cold hands and feet, among others. As the body becomes more deficient in iron and anemia worsens, the symptoms worsen as well.How is IDA diagnosedA diagnosis is made primarily through blood tests. The doctor checks your hematocrit, the percentage of your blood volume made up of red blood cells and hemoglobin. lower than normal hemoglobin level indicates anemia. Also, blood tests for IDA typically include measurement of ferritin, protein that helps store iron in your body. When the level of ferritin is low, usually the level of iron is, too. If patient tests positive for IDA, additional tests may be ordered to identify an underlying cause.Does IDA lead to health complicationsMild cases of IDA usually dont cause complications. However, left untreated, IDA can increase in severity and contribute to serious health problems. For example, it may lead to rapid or irregular heartbeat, complicated pregnancy that can put the mother at risk for premature delivery or low-birth-weight baby, and delayed growth in infants and children. The good news is that, because IDA is easily treatable, its potential health consequences are generally avoidable.How is IDA treatedIts essential to increase the amount of iron in your diet. Foods rich in iron include meat, fish, poultry, and whole grain breads. However, in most cases of IDA, diet alone isnt enough to correct the problem. Iron supplementation is usually needed for several months. Your doctor has prescribed Ferralet (R) 90, safe and effective iron supplement to help restore your bodys iron to normal levels. Plus, it offers the convenience of once-daily dosing. Together with an iron-rich diet, taking Ferralet (R) 90 every day can make big difference in helping restore your bodys iron, and with it your energy and overall feeling of well-being. A diet consistently low in iron. Blood loss due to heavy menstrual bleeding. Poor iron absorption from food due to intestinal surgery or diseases of the intestine. Pregnancy (when the need for iron increases significantly).

SPL UNCLASSIFIED SECTION.

Folic Acid. 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 these products since folic acid may mask the symptoms of pernicious anemia.

WARNINGS SECTION.

WARNING. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin 12 is deficient.