Label: PRENATRIX- ferrous fumarate, folic acid tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 20, 2021

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  • DESCRIPTION:

    \Each caplet contains:

    Vitamin A (as retinyl acetate)………………………….. 1500 mcg
    Vitamin C (as ascorbic acid)……………………………… 120 mg
    Vitamin D3 (as cholecalciferol)…………………………… 20 mcg
    Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg
    Thiamin (as thiamine mononitrate)………………………… 3 mg
    Riboflavin (vitamin B2)……………………………………. 3.4 mg
    Niacin (as niacinamide)…………………………………… 20 mg
    Vitamin B6 (as pyridoxine hydrochloride)…………………. 50 mg
    Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)
    Vitamin B12 (as cyanocobalamin)………………………… 10 mcg
    Choline (as Choline Bitartrate)…………………………….. 55 mg
    Calcium (as calcium carbonate)…………………………. 200 mg
    Iron (as ferrous fumarate)………………………………… 27 mg
    Iodine (as potassium iodine)…………………………….150 mcg
    Magnesium (as magnesium oxide)……………………… 200 mg
    Zinc (as zinc oxide)……………………………………….. 25 mg
    Selenium (as selinium amino acid chelate)………………. 70 mcg
    Manganese (as manganese sulfate)……………………… 2.6 mg
    Chromium (as chromium polynicotinate)……………….. 45 mcg
    Molybdenum (as molybdenum amino acid chelate)……… 50 mcg



    Other Ingredients: BHT, dicalcium phosphate, croscarmellose sodium,
    crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline
    cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate,
    sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose,
    Clear Coating: (hydroxypropyl methylcellulose, PEG-8).

  • Indications

    Prenatrix is indicated to provide vitamins and minerals to women
    throughout pregnancy and during the postnatal period for both lactating and non-lactating
    mothers, and throughout the childbearing years.
    Prenatrix may be beneficial in improving the nutritional status of women prior to conception.

  • 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.

  • BOXED WARNING (What is this?)

    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 B12 is deficient.

    Precautions

    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:


    Prenatrix 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 Prenatrix after meals may control
    occasional gastrointestinal disturbances. Prenatrix 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 usual 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. Prenatrix 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) One (1) Prenatrix caplet
    daily, between meals or as directed by a physician. Do not administer to children under the age
    of 12.

  • HOW SUPPLIED

    Prenatrix are yellow to brown speckled, oblong, coated caplets with "PT A18" debossed horizontally on one side,
    bottles containing 30 caplets – NDC 59088-166-54. 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 if 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 877-921-7873.

  • Prenatrix

    Manufactured by:
    PureTek Corporation
    Panorama City, CA 91402
    For questions or information
    call toll-free: 877-921-7873

    label

  • INGREDIENTS AND APPEARANCE
    PRENATRIX 
    ferrous fumarate, folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-166
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE200 mg
    MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+)2.6 mg
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL20 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE50 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN10 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM50 ug
    CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE55 mg
    CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE45 ug
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM70 ug
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE150 ug
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM ASCORBATE (UNII: S033EH8359)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GELATIN (UNII: 2G86QN327L)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SUCROSE (UNII: C151H8M554)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
    Product Characteristics
    Coloryellow ((Clear Coated Yellow to Brown speckled)) Scoreno score
    ShapeCAPSULE ((Oblong Caplet)) Size19mm
    FlavorImprint Code PT;A18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-166-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/29/2020
    Labeler - PureTek Corporation (785961046)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046label(59088-166) , manufacture(59088-166) , pack(59088-166) , relabel(59088-166)