Home > Drugs A-Z > FerraPlus 90

FerraPlus 90 (TRIGEN Laboratories, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 90 TABLET, FILM COATED in 1 BOTTLE (13811-012-90) Label Information

Complete FerraPlus 90 Information

  • DESCRIPTION

    FerraPlus 90 is a dark grey, oval, film-coated tablet, debossed "TL012".  Each dark grey film-coated tablet for oral administration contains:

    Supplement Facts

    Servings per Bottle: 90

     Serving Size: 1 Tablet

    Each Tablet Contains:                                                                                                                                               %DV Adults only  

    Docusate Sodium                                                                      50 mg                                                                                     15%

    Folic Acid                                                                                     1 mg                                                                                    250%

    Iron (carbonyl iron)                                                                      90 mg                                                                                      15%

    Vitamin B12 (cyanocobalamin)                                                   12 mcg                                                                                     15%

    Vitamin C (ascorbic acid)                                                           120 mg                                                                                     15%

    Inactive Ingredients:

    Microcrystalline Cellulose, Di Calcium Phosphate, TriPotassium Citrate, Sodium Carboxymethyl Cellulose, Acacia, Povidone K30, Croscarmellose Sodium, Fumed Silica, Stearic Acid, Magnesium Stearate, Citric Acid, Dextrin, Dextrose, Lecithin, and Sodium Citrate.



  • 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 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 erythropoiesis. 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, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.


  • INDICATIONS AND USAGE

    FerraPlus 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, post-surgical convalescence, and dietary needs.


  • CONTRAINDICATIONS

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


  • WARNINGS

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


  • Warning

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

    General

    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 FerraPlus 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 a dose change is indicated.

    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.


  • 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 INTERACTIONS

    Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.


  • OVERDOSAGE

    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, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.


  • DOSAGE AND ADMINISTRATION

    One tablet daily or as directed by a physician.

    NOTICE:Contact with moisture can discolor or erode the tablet. Do not chew tablet.


  • HOW SUPPLIED

    FerraPlus 90 is packaged in bottles of 90 tablets.

    Product Code: 13811-012-90


  • STORAGE

    Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F) [See USP controlled room temperature].

    Dispense in a tight container with a child-resistant closure.


  • HEALTH CLAIM

    Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

     

    KEEP OUT OF THE REACH OF CHILDREN.

    Rx Only

    All prescriptions using this product shall be pursuant to statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

    Manufactured For:
    TRIGEN Laboratories, Inc., Sayreville, NJ 08872
    www.trigenlab.com

    Rev. 07/13



  • PRINCIPAL DISPLAY PANEL

    13811-012-90
    Rx Only

    FerraPlus 90
    Tablets

    WITH 90 MG CARBONYL IRON

    90 COATED TABLETS

    TRIGEN
    LABORATORIES

    FerraPlus 90

    FerraPlus 90



  • INGREDIENTS AND APPEARANCE
    FERRAPLUS 90 
    docusate sodium, folic acid, carbonyl iron, cyanocobalamin, and ascorbic acid tablet, film coated
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-012
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 90 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ACACIA (UNII: 5C5403N26O)  
    POVIDONE K30 (UNII: U725QWY32X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:13811-012-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 09/01/2011
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    imprint
    scoring 1
    shape
    size (solid drugs) 15 mm
    Labeler - Trigen Laboratories, LLC (830479668)