ZATEAN-PN DHA (LEVOMEFOLIC ACID, FOLIC ACID, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, AND DOCONEXE

ZATEAN-PN DHA (LEVOMEFOLIC ACID, FOLIC ACID, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, AND DOCONEXE
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NDC 13811-580-30
Set ID f6ee5344-98ea-45a5-85be-712ef43a809e
Category DIETARY SUPPLEMENT
Packager Trigen Laboratories, LLC
Generic Name
Product Class
Product Number
Application Number
  • SUPPLEMENT FACTS

    Zatean Pn DHA Supplement Facts Panel Rev. 07/2019

    Other Ingredients: Gelatin Capsule (Bovine gelatin, glycerin, purified water, sorbitol, ethyl vanillin, titanium dioxide, FD&C Yellow #5, FD&C Blue #1), yellow beeswax, soybean oil, soy lecithin, natural & artificial orange cream flavor, citric acid, potassium citrate


    THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVY).

     
    Zatean™- Pn DHA is a prescription prenatal/postnatal multivitamin/ mineral softgel with an essential fatty acid and is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

  • CONTRAINDICATIONS

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

  • WARNING

    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.
  • PRECAUTIONS

    General: Folic acid alone is an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive. Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency.

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

    This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

  • DRUG 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.

    There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

  • 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.

  • DESCRIPTION

    Zatean™ - Pn DHA is an oblong shaped, dark green soft gelatin capsule containing brown paste, laser etched with white “T580”.

  • DIRECTIONS FOR USE

    Take one softgel capsule by mouth daily or as prescribed by a physician.

  • HOW SUPPLIED

    Zatean™ - Pn DHA is dispensed in bottles of 30 softgel capsules.

    PRODUCT CODE 13811-580-30

  • STORAGE

    Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

  • HEALTH CLAIM

    KEEP OUT OF 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, LLC at 1-877-482-3788 or FDA at 1-800-FDA-1088.


                                                                                                              Rev. 05/2020

    Customer Service: 1-877-482-3788


    Manufactured for:
    Trigen Laboratories, LLC
    Bridgewater, NJ 08807

    Trigen Logo

  • PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

    13811-580-30

    Zatean™-Pn
    DHA

    Softgels

    30 SOFTGELS

    TRIGEN
    LABORATORIES

    Zatean-Pn DHA Bottle LabelZatean-Pn DHA Bottle Label

  • INGREDIENTS AND APPEARANCE
    ZATEAN-PN DHA 
    levomefolic acid, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, and doconexent capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-580
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Levomefolic Acid (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) Levomefolic Acid600 ug
    Folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) Folic acid400 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID85 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL200 [iU]
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL10 [iU]
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    calcium carbonate (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) calcium carbonate140 mg
    ferrous fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    magnesium oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) magnesium oxide45 mg
    Doconexent (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) Doconexent300 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
    glycerin (UNII: PDC6A3C0OX)  
    soybean oil (UNII: 241ATL177A)  
    water (UNII: 059QF0KO0R)  
    yellow wax (UNII: 2ZA36H0S2V)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    potassium citrate anhydrous (UNII: 86R1NVR0HW)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    ethyl vanillin (UNII: YC9ST449YJ)  
    FD&C yellow no. 5 (UNII: I753WB2F1M)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-580-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/01/2010
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    imprint
    scoring1
    shape
    size (solid drugs)26 mm
    Labeler - Trigen Laboratories, LLC (830479668)