Label: PRENATE AM- .pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid tablet, coated

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

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Drug Label Information

Updated January 5, 2018

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  • SPL UNCLASSIFIED SECTION

    Dietary Supplement
    Rx prenatal vitamin with B vitamins and Ginger
    With
    Quatrefolic ®

    Rx Only

  • DESCRIPTION

    DESCRIPTION: PRENATE ® AM is a yellow, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "Prenate" on one side and "AM" on the other.

    Supplement Facts
    Serving Size: 1 Tablet
    Each Tablet Contains:
    Vitamin B6 (Pyridoxine Hydrochloride)75 mg
    Vitamin B12 (Cyanocobalamin)12 mcg
    Calcium (as Calcium Carbonate)200 mg
    Folate (as 1.1 mg Quatrefolic® ((6S)-5,methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg)1 mg
    Ginger Extract500 mg
    Lingonberry25 mg
  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: Methocel K, stearic acid, magnesium stearate and silicon dioxide, dicalcium phosphate

  • BOXED WARNING (What is this?)

    PRECAUTIONS: Concomitant use of ginger in patients with bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding. Folic acid alone is 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 neurological manifestations progress. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and any drugs, herbs and/or supplements consumption should be considered.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: One tablet daily or as directed by your doctor.

  • SPL UNCLASSIFIED SECTION

    THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

  • STORAGE AND HANDLING

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

  • WARNINGS

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    Avion Pharmaceuticals, LLC
    Atlanta, GA 30350 1-888-61-AVION            Rev. 0513

  • SPL UNCLASSIFIED SECTION

    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.

  • SPL UNCLASSIFIED SECTION

    *Quatrefolic ® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

  • SPL UNCLASSIFIED SECTION

    PRENATE ® AM is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    75854-307-30

    Prenate ® Am
    Dietary Supplement
    Rx prenatal vitamin with B vitamins and Ginger
    With
    Quatrefolic ®

    PRENATE® AM’s formulation eases symptoms
    commonly associated with pregnancy, including
    nausea and vomiting.

    30 Tablets
    Rx Only

    Avion
    PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL - 30 tablets
  • INGREDIENTS AND APPEARANCE
    PRENATE AM 
    .pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75854-307
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE75 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    Inactive Ingredients
    Ingredient NameStrength
    GINGER (UNII: C5529G5JPQ) 500 mg
    LINGONBERRY (UNII: 0UNK9RZQ7X) 25 mg
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeOVALSize22mm
    FlavorImprint Code Prenate;AM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75854-307-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/15/2013
    Labeler - Avion Pharmaceuticals, LLC (965450542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avion Pharmaceuticals, LLC040348516manufacture(75854-307)
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