ADVERSE REACTIONS SECTION.


ADVERSEREACTIONS:. Adverse reactionswith iron therapy may include GI irritation, constipation, diarrhea,nausea, vomiting, and dark stools. Adverse reactions with iron therapyare usually transient. Allergic sensitization has been reported followingboth oral and parenteral administration of folic acid.

BOXED WARNING SECTION.


Warning: Accidentaloverdose of iron-containing products is leading causeof fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THEREACH OF CHILDREN. In case of accidental overdose, call doctor orpoison control center immediately.

CLINICAL PHARMACOLOGY SECTION.


CLINICALPHARMACOLOGY:. Oral iron is absorbed most efficientlywhen administered between meals. Iron is critical for normal hemoglobinsynthesis to maintain oxygen transport for energy production and properfunction of cells. Adequate amounts of iron are necessary for effectiveerythropolesis. Iron also serves as cofactor of several essentialenzymes, Including cytochromes, which are involved in electron transport.Folic acid is required for nucleoprotein synthesis and the maintenanceof normal erytropolesis. Folic acid is the precursor of tetrahydrofolicacid, which is involved as cofactor for transformylation reactionsIn the biosynthesis of purines and thymidylates of nucleic acids.Deficiency of folic acid may account for the defective deoxyribonucleicacid (DNA) synthesis that leads to megaloblast formation and megaloblasticmacrocytic anemias. Vitamin B12 is essentialto growth, cell reproduction, hematopolesis, nucleic acid, and myelinsynthesis. Deficiency may result in megaloblastic anemia or perniciousanemia.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS:. Hypersensitivity to any of theingredients. Hemolytic anemia, hemochromatosis, and hemosiderosisare contraindications to iron therapy.

DESCRIPTION SECTION.


DESCRIPTION:. Each green film-coated tablet for oral administrationcontains:.

DOSAGE & ADMINISTRATION SECTION.


DOSAGEAND ADMINISTRATION. One tablet daily or as directed by physician.Do not chew tablet.

DRUG INTERACTIONS SECTION.


GeriatricUse:. Dosing for elderly patientsshould be administered with caution. Due to the greater frequencyof decreased hepatic, renal, or cardiac function, and of concomitantdisease or other drug therapy, dosing should start at the lower endof the dosing range.

GENERAL PRECAUTIONS SECTION.


General:. Take hours after meals. Do not exceed recommendeddose. Discontinue use if symptoms of intolerance appear. The typeof anemia and underlying cause or causes should be determined beforestarting therapy with BioFerr(TM) 90 tablets. Ensure Hgb, Hct, and reticulocytecount are determined before starting therapy to determine if it needsto be continued without change or if dose change is indicated. Thisproduct contains FD&C Yellow No. (tartrazine) which may causeallergic-type reactions (including bronchial asthma) in certain susceptiblepersons. Although the overall incidence of FD&C Yellow No. (tartrazine)sensitivity in the general population is low, it is frequently seenin patients who also have aspirin hypersensitivity.

HOW SUPPLIED SECTION.


HOW SUPPLIED:. BioFerr(TM) 90 (NDC 44523-732-90) isa green, modified rectangle shaped, film-coated tablet, debossed withF7 on one side and blank on the other, and packaged in bottles of90.

INACTIVE INGREDIENT SECTION.


Inactive Ingredients:. Povidone, croscarmellose sodium,acrylic resin, color added, magnesium stearate, FD&C Yellow No.5, magnesium silicate, FD&C Blue No. 1, polyethylene glycol, vitaminA palmitate, ethyl vanillin.

INDICATIONS & USAGE SECTION.


INDICATIONSAND USAGE:. BioFerr(TM) 90 isindicated for the treatment of all anemias that are responsive tooral iron therapy. These include: hypochromic anemia associated withpregnancy, chronic and/or acute blood loss, metabolic disease, post-surgicalconvalescence, and dietary needs.

INFORMATION FOR PATIENTS SECTION.


FolicAcid:. Folic acid in dosesabove 0.1 mg daily may obscure pernicious anemia in that hematologicremission can occur while neurological manifestations remain progressive.Pernicious anemia should be excluded before using these products sincefolic acid may mask the symptoms of pernicious anemia.

LABORATORY TESTS SECTION.


PediatricUse:. Safety and effectivenessin pediatric patients have not been established.

OVERDOSAGE SECTION.


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

OTC - ACTIVE INGREDIENT SECTION.


Iron (Carbonyl iron, ferrousgluconate)90 mgFolic Acid1 mgVitamin B12 (Cyanocobalamin)12 mcgVitamin (Ascorbic acid)119 mgDocusate sodium50 mg. Inactive Ingredients:. Povidone, croscarmellose sodium,acrylic resin, color added, magnesium stearate, FD&C Yellow No.5, magnesium silicate, FD&C Blue No. 1, polyethylene glycol, vitaminA palmitate, ethyl vanillin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


BioFerr(TM)9090 mg Dual-Iron TabletsNDC 44523-732-90 BioFerr 90 Label.

PRECAUTIONS SECTION.


PRECAUTIONS:. General:. Take hours after meals. Do not exceed recommendeddose. Discontinue use if symptoms of intolerance appear. The typeof anemia and underlying cause or causes should be determined beforestarting therapy with BioFerr(TM) 90 tablets. Ensure Hgb, Hct, and reticulocytecount are determined before starting therapy to determine if it needsto be continued without change or if dose change is indicated. Thisproduct contains FD&C Yellow No. (tartrazine) which may causeallergic-type reactions (including bronchial asthma) in certain susceptiblepersons. Although the overall incidence of FD&C Yellow No. (tartrazine)sensitivity in the general population is low, it is frequently seenin patients who also have aspirin hypersensitivity.. FolicAcid:. Folic acid in dosesabove 0.1 mg daily may obscure pernicious anemia in that hematologicremission can occur while neurological manifestations remain progressive.Pernicious anemia should be excluded before using these products sincefolic acid may mask the symptoms of pernicious anemia.. PediatricUse:. Safety and effectivenessin pediatric patients have not been established.. GeriatricUse:. Dosing for elderly patientsshould be administered with caution. Due to the greater frequencyof decreased hepatic, renal, or cardiac function, and of concomitantdisease or other drug therapy, dosing should start at the lower endof the dosing range.

SPL UNCLASSIFIED SECTION.


NOTICE:. Contact with moisture can discoloror erode the tablet.

STORAGE AND HANDLING SECTION.


STORAGE:. Store at 20C to 25C (68F to 77F). Excursionspermitted between 15C and 30C (between 59F and 86F). (See USPControlled Room Temperature.).

WARNINGS SECTION.


WARNING:. Folic acid alone is improper therapy in the treatmentof pernicious anemia and other megaloblastic anemia where vitaminB12 is deficient.