Label: ZATEAN-PN PLUS- levomefolate calcium, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent capsule 

  • NDC Code(s): 13811-582-30
  • Packager: Trigen Laboratories, Inc.
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated 05/13

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  • HEALTH CLAIM

    Rx Only

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  • DESCRIPTION

    Zatean™ - Pn Plus is a prescription prenatal/postnatal multivitamin/ mineral softgel with an essential fatty acid. Each softgel capsule is oblong, green and imprinted with "T582" in white ink.

    Supplement Facts
    Servings per Bottle: 30
    Serving Size: 1 Softgel Capsule
    Each Softgel Capsule contains
    %DV for Pregnant and
    Lactating Women
    *
    from at least 340 mg omega-3s derived from at least 390 mg purified fish oils.
    Daily value not established. THIS PRODUCT CONTAINS SOY AND FISH OIL.
    Folate (L-methylfolate, or 6(S)-5-MTHF 600 mcg) folic acid, USP 400 mcg) 1 mg 125%
    Vitamin C 85 mg 142%
    Vitamin D3 200 IU 50%
    Vitamin E 10 IU 33%
    Vitamin B6 25 mg 1000%
    Vitamin B12 12 mcg 150%
    Biotin 250 mcg 83%
    Calcium (calcium carbonate) 140 mg 11%
    Iron (ferrous fumarate) 28 mg 156%
    Iodine (potassium iodide) 150 mcg 100%
    Magnesium (magnesium oxide) 45 mg 10%
    Docosahexaenoic Acid (DHA) 300 mg*
    Eicosapentaenoic Acid (EPA) 40 mg*

    Inactive Ingredients: Caramel, Citric Acid, Ethyl Vanillin, FD&C Blue # 1, FD&C Yellow # 5, Gelatin, Glycerin, Lecithin, Natural Creamy Orange Flavor, Purified Water, Sorbitol, Titanium Dioxide, Tripotassium Citrate, Yellow Bees Wax.

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  • INDICATIONS AND USAGE

    Zatean™ - Pn Plus is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

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  • CONTRAINDICATIONS

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.

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  • WARNING

    Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids - including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

    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.

    THIS PRODUCT CONTAINS SOY AND FISH OIL.

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  • CAUTION

    Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

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  • PRECAUTIONS

    General

    Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.

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  • PATIENT INFORMATION

    Zatean™ - Pn Plus is a prescription vitamin for use only under the direction and supervision of a licensed physician.

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  • INTERACTIONS

    Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

    Drugs which may interact with folate include:

    • Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the levels of this AED in the blood and allowing breakthrough seizures to occur.
    • Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
    • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
    • Colestipol: Reduces folic acid absorption and reduces serum folate levels.
    • Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
    • Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
    • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
    • Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
    • Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
    • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
    • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
    • Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts.
    • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
    • Smoking and alcohol: Reduced serum folate levels have been noted.
    • Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
    • Metformin treatment in patients with type 2 diabetes decreases serum folate.
    • Warfarin can produce significant impairment in folate status after a 6 - month therapy.
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  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates, including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

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  • DOSAGE AND ADMINISTRATION

    Before, during, and or after pregnancy, one tablet daily or as prescribed by a physician.

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  • HOW SUPPLIED

    Zatean™ - Pn Plus is dispensed in bottles of 30 softgels.

    PRODUCT CODE 13811-582-30

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  • WARNINGS

    KEEP OUT OF REACH OF CHILDREN

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  • HEALTH CLAIM

    Rx Only

    All prescriptions using this product shall be pursuant to state 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. 02/13

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  • PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

    13811-582-30
    Rx Only

    Zatean-Pn
    Plus

    Softgels

    30 SOFTGELS

    TRIGEN
    LABORATORIES

    PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
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  • INGREDIENTS AND APPEARANCE
    ZATEAN-PN PLUS 
    levomefolate calcium, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent, and icosapent capsule
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-582
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM 600 ug
    folic acid (FOLIC ACID) folic acid 400 ug
    ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 85 mg
    CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 200 [iU]
    .ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 10 [iU]
    PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 25 mg
    CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
    Biotin (Biotin) Biotin 250 ug
    calcium carbonate (CALCIUM CATION) calcium carbonate 140 mg
    ferrous fumarate (FERROUS CATION) FERROUS CATION 28 mg
    potassium iodide (IODIDE ION) potassium iodide 150 ug
    magnesium oxide (MAGNESIUM CATION) magnesium oxide 45 mg
    Doconexent (DOCONEXENT) Doconexent 300 mg
    Icosapent (ICOSAPENT) Icosapent 40 ug
    Inactive Ingredients
    Ingredient Name Strength
    caramel  
    citric acid monohydrate  
    ethyl vanillin  
    FD&C Blue no. 1  
    FD&C Yellow no. 5  
    gelatin  
    glycerin  
    lecithin, soybean  
    water  
    sorbitol  
    titanium dioxide  
    potassium citrate anhydrous  
    yellow wax  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL (oblong) Size 26mm
    Flavor Imprint Code T582
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:13811-582-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 05/01/2010
    Labeler - Trigen Laboratories, Inc. (830479668)
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