Label: FOLIFLEX- ferrous fumarate, folic acid tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 19, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DESCRIPTION:

    Full Prescribing Information:

    Each Serving Size of 2 caplets contain:

    Supplement

    Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).

  • INDICATIONS:

    Foliflex TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.

  • CONTRAINDICATIONS:

    This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

  • 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. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

    Precaution Section

    Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.


    There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.


    The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.


    For use on the order of a healthcare practitioner.
    Call your doctor about side effects. To report side effects, call PureTek Corporation at
    1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Drug Interactions:

    Foliflex TM is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, or Clopidogrel).

    Adverse Reactions:

    Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.


    Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Foliflex TM after meals may control occasional gastrointestinal disturbances. Foliflex TM is best absorbed when taken at
    bedtime.


    Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

  • OVERDOSE:

    Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Foliflex TM should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children.

    Treatment:

    For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

  • DOSAGE AND ADMINISTRATION:

    Adults (persons over 12 years of age) Two (2) Foliflex TM caplet daily, between meals, or as directed by a physician. Do not administer to children under the age of 12.

  • HOW SUPPLIED:

    Foliflex TM are yellow with slightly brown speckled, oblong, coated caplets. Bottles contain 60 caplets – NDC 59088-480-58. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

    Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

  • STORAGE:

    Do not use it if the bottle seal is broken.
    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP].
    Protect from light and moisture and avoid excessive heat.
    To report a serious adverse event or to obtain product information, contact
    1-877-921-7873.

  • Chronocap

    Chronocap 1Chronocap 2

  • Foliflex TM

    Manufactured in the USA by:
    PureTek Corporation
    Panorama City, CA 91402
    Questions? Call toll-free:
    1-877-921-7873

    label

  • INGREDIENTS AND APPEARANCE
    FOLIFLEX 
    ferrous fumarate, folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-480
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID250 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL13.75 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-45 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3.25 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.35 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE22.5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE6 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID500 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN13 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN100 ug
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID15 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION75 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION9 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION25 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION37.5 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 mg
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM30 ug
    CUPROUS OXIDE (UNII: T8BEA5064F) (CUPROUS OXIDE - UNII:T8BEA5064F) CUPROUS OXIDE1 mg
    MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+)0.75 mg
    CHROMIUM NICOTINATE (UNII: A150AY412V) (NIACIN - UNII:2679MF687A) CHROMIUM NICOTINATE37.5 ug
    MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM25 ug
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION24.5 mg
    BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON25 ug
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Coloryellow (With Slightly Brown Specks) Scoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-480-5860 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/25/2021
    Labeler - PureTek Corporation (785961046)