Label: PRENATE ESSENTIAL- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated

  • NDC Code(s): 75854-313-30
  • Packager: Avion Pharmaceuticals, LLC
  • 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 January 7, 2021

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

  • SPL UNCLASSIFIED SECTION

    Rx prenatal vitamin & DHA

    Rx Only

  • DESCRIPTION

    DESCRIPTION: PRENATE ESSENTIAL ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is green in color, opaque, and imprinted with "Prenate" on one side and blank on the other.

    Prenate Essencial

    PRENATE ESSENTIAL ® contains fish oil and soy.

    OTHER INGREDIENTS: Capsule gelatin (gelatin, sorbitol, glycerin, purified water, turmeric, and sodium copper chlorophyllin), soy lecithin, yellow beeswax and soybean oil.

  • INDICATIONS & USAGE

    INDICATIONS: PRENATE ESSENTIAL ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

    PRENATE ESSENTIAL ® can also be beneficial in improving the nutritional status of women prior to conception

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: PRENATE ESSENTIAL ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • WARNINGS

    WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

  • PRECAUTIONS

    PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

  • 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.

  • ADVERSE REACTIONS

    ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

  • HOW SUPPLIED

    HOW SUPPLIED: Bottles of 30 softgels (75854-313-30).

    The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR: Avion Pharmaceuticals, LLC

    Atlanta, GA 30005

    1-888-61-AVION

    Rev. 0519-01

    Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.

    Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    75854-313-30

    PRENATE ESSENTIAL ®

    Rx prenatal vitamin & DHA

    • Key vitamins, minerals, and DHA support nutrition

    GLUTEN FREE

    Rx Only

    Dietary Supplement

    30 Softgels

    Essencial

  • INGREDIENTS AND APPEARANCE
    PRENATE ESSENTIAL 
    ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75854-313
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT40 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID90 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL220 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-10 [iU]
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE26 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID400 ug
    5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (5-METHYLTETRAHYDROFOLIC ACID - UNII:TYK22LML8F) 5-METHYLTETRAHYDROFOLIC ACID600 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN13 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN280 ug
    CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION155 mg
    FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION18 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION50 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT300 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WATER (UNII: 059QF0KO0R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Colorgreen, yellow (opaque) Scoreno score
    ShapeOVALSize24mm
    FlavorImprint Code Prenate
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75854-313-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/18/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/18/2014
    Labeler - Avion Pharmaceuticals, LLC (040348516)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avion Pharmaceuticals, LLC040348516manufacture(75854-313)