Label: BIOFERR 90- dual-iron tablet, film coated
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated June 18, 2014
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- BOXED WARNING (What is this?)
Iron (Carbonyl iron, ferrous gluconate) 90 mg Folic Acid 1 mg Vitamin B12 (Cyanocobalamin) 12 mcg Vitamin C (Ascorbic acid) 119 mg Docusate sodium 50 mg
Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport for energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropolesis. Iron also serves as a 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 erytropolesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a 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, hematopolesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.
- INDICATIONS AND USAGE:
Take 2 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 BioFerr™ 90 tablets. Ensure Hgb, Hct, and reticulocyte count are determined before starting therapy to determine if it needs to be continued without change or if a dose change is indicated. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
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.
- ADVERSE REACTIONS:
- DRUG INTERACTIONS:
Symptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematernesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED:
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
dual-iron tablet, film coated
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44523-732 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 138 mg IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 88.5 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 55 mg FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 13.2 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.4 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 16.8 ug Inactive Ingredients Ingredient Name Strength POVIDONES (UNII: FZ989GH94E) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM STEARATE (UNII: 70097M6I30) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) MAGNESIUM SILICATE (UNII: 9B9691B2N9) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ETHYL VANILLIN (UNII: YC9ST449YJ) Product Characteristics Color GREEN Score no score Shape RECTANGLE (modified rectangle) Size 9mm Flavor Imprint Code F7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44523-732-90 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 07/01/2014 Labeler - Biocomp Pharma, Inc. (829249718) Registrant - Mission Pharmacal Company (927726893) Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 MANUFACTURE(44523-732)