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.DRUG INTERACTIONSPrescriber should be aware of number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.OVERDOSAGESymptoms: 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.

BOXED WARNING SECTION.

WARNING: If you are pregnant, nursing or taking medication, consult your doctor before use. Accidental overdose of iron containing products is leading cause of fatal poisoning in children under 6. 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 B12 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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. One tablet daily or as directed by physician.NOTICEContact with moisture can discolor or erode the tablet. Do not chew tablet.

HOW SUPPLIED SECTION.

HOW SUPPLIED. NEONATAL FE (NDC 73317-8222-3) is green, round shaped, film-coated tablet and packaged in bottles of 90. Store at 25C (77F). Excursions permitted to 15-30C (59-86F). (See USP Controlled Room Temperature).To report serious adverse event or obtain product information, call 866-760-6565Dispensed by PrescriptionThis product is prescription-folate with or without other dietary ingredients that due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product. This product may be administered only under physicians supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.1. Federal Register Notice of August 2, 1973 (38 FR 20750)2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)3. Federal Register Notice of March 5, 1996 (61 FR 8760)AUM Pharmaceuticals does not represent these product codes to be National Drug Codes (NDC) .Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply chain control including pharmacies.THERAPEUTIC GUIDELINES FOR THE PATIENTSome 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 NEONATAL FE, 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 NEONATAL FE every day can make big difference in helping restore your bodys iron, and with it your energy and overall feeling of well-being.If you have questions about NEONATAL FE please call: 866-760-6565AUM Pharmaceuticals320 Oser Ave,Hauppauge, NY 11788-3608. 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).

INDICATIONS & USAGE SECTION.

INDICATIONS. NEONATAL FE Rx Prenatal Vitamin With ferronyl iron Vitamin 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.

OTC - ACTIVE INGREDIENT SECTION.

DESCRIPTION. Each green film-coated tablet for oral administration contains:Iron (Ferronyl) 90 mgFolic Acid 1000 mcgVitamin B12 (Cyanocobalamin) 12 mcgVitamin (Ascorbic acid) 120 mgInactive Ingredients: Microcrystalline cellulose, DI-Calcium phosphate, stearic acid, magnesium stearate, croscarmellose sodium, silicon dioxide, Titanium dioxide, HPMC E15, HPMC E5/E6, FD&C YELLOW 5(LAKE), FD&C BLUE (LAKE ), FD&C YELLOW (LAKE).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Container Label.

PRECAUTIONS SECTION.

PRECAUTIONS. 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.GeneralTake 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 NEONATAL FE 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 AcidFolic 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 UseSafety and effectiveness in pediatric patients have not been established.Geriatric UseDosing 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.

WARNINGS SECTION.

WARNING. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.WarningAccidental 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.