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FerraPlus 90 (TRIGEN Laboratories, Inc.)

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TABLET, FILM COATED 90 TABLET, FILM COATED in 1 BOTTLE (13811-012-90) Label Information

Complete FerraPlus 90 Information

  • SUPPLEMENT FACTS

    SupplementPanel

    FerraPlus 90 is an Iron Supplement Multivitamin/Mineral indicated for the distinctive nutritional requirements of persons being treated for iron deficiencies by a physician. THIS PRODUCT IS NOT INDICATED FOR USE IN CHILDREN.



  • 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 box

  • 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 or if a dose change is indicated.

    Folic Acid: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia assessment, such 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 of this product have not been established in pediatric patients.


    Geriatric Use: Safety and effectiveness of this product have not been established in elderly patients.


  • DRUG INTERACTIONS

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


  • 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.


  • 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.


  • DESCRIPTION

    FerraPlus 90 is a grey speckled, oval, film-coated tablet, debossed "TL012".


  • DIRECTIONS FOR USE

    One tablet daily or as directed by a physician.  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]. Protect from moisture (contact with moisture can discolor or erode the tablet).  Dispense in a tight container with a child-resistant closure.


  • HEALTH CLAIM

    KEEP OUT OF THE REACH OF CHILDREN.

    For use on the order of a healthcare practitioner.

    Call your doctor about side effects.  To report side effects, call Trigen Laboratories at 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

     

    Customer Service: 1-888-987-4436                                                                                                            Rev. 07/2018

     

     Manufactured for:                                                                                                                        trigen logo

    Trigen Laboratories, LLC

    Bridgewater, NJ 08807



  • PRINCIPAL DISPLAY PANEL

    13811-012-90

    FerraPlus 90
    Tablets

    WITH 90 MG CARBONYL IRON

    90 COATED TABLETS

    TRIGEN
    LABORATORIES

    Rev072018

  • 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)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    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)