Label: PROMETA- ferrous fumarate, folic acid tablet
PRENATRYL- ferrous fumarate, folic acid tablet

  • NDC Code(s): 59088-169-54, 59088-172-54
  • Packager: PureTek Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 April 9, 2021

If you are a consumer or patient please visit this version.

  • DESCRIPTION:

    Full Prescribing Information:

    Each caplet contains:

    Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU)
    Vitamin C (as ascorbic acid)……………………………… 120 mg
    Vitamin D3 (as cholecalciferol)………………….. 20 mcg (800 IU)
    Vitamin E (dl-alpha tocopheryl acetate)…………… 30 mg (30 IU)
    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 selenium 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:
    Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide,
    stearic acid, Clear coating: (hydroxypropyl methylcellulose, PEG-8).

  • Indications

    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.

    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 B 12 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 B 12 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:

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

  • HOW SUPPLIED

    Prometa™ are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-172-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

    Prenatryl™ are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-169-54. 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 1-877-921-7873.

  • Prometa

    Manufactured by:
    PureTek Corporation

    Panorama City, CA 91402
    For questions or information
    call toll-free: 1-877-921-7873

    Label

  • Prenatryl​™

    Manufactured in the USA by:

    PureTek Corporation
    Panorama City, CA 91402
    Questions? Call toll-free:
    1-877-921-7873

    Label

  • INGREDIENTS AND APPEARANCE
    PROMETA 
    ferrous fumarate, folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-172
    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
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM70 ug
    CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE45 ug
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE150 ug
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorbrown (beige speckled caplets) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-172-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/11/2021
    PRENATRYL 
    ferrous fumarate, folic acid tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-169
    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
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM70 ug
    CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE45 ug
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE150 ug
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorbrown (beige speckled caplets) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-169-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/30/2020
    Labeler - PureTek Corporation (785961046)