Label: PRENATE PIXIE- ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated

  • NDC Code(s): 75854-316-30
  • Packager: Avion Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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 5, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • BOXED WARNING(What is this?)

    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.

    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.

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  • DESCRIPTION

    DESCRIPTION: PRENATE ® PIXIE is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”.

    Supplement Facts
    Serving Size: 1 Softgel
    Amount per Serving: % Daily
    Value
    % Daily
    Value
    (Pregnant &
    Lactating
    Women)
    Vitamin C (as ascorbic acid) 30 mg 50% 50%
    Biotin 75 mcg 25% 25%
    Vitamin D3
    (as cholecalciferol)
    500 IU 125% 125%
    Vitamin B12
    (as cyanocobalamin)
    13 mcg 217% 163%
    Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg) 1 mg 250% 125%
    Iron (as ferrous asparto glycinate) Sumalate ® 10 mg 56% 56%
    Iodine (as potassium iodide) 150 mcg 100% 100%
    Vitamin B6 (as pyridoxine HCl) 5 mg 250% 200%
    Vitamin E
    (as dl-alpha tocopheryl acetate)
    10 IU 33% 33%
    Docosahexaenoic acid (DHA) 200 mg
    Blueberry extract
    (vaccinium spp.)
    5 mg

    † Daily Value (DV) not established.

    PRENATE ® PIXIE contains fish oil and soy.

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  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: Bovine gelatin, glycerin, yellow beeswax, soy lecithin, vegetable shortening, purified water, titanium dioxide, FD&C Red #40, caramel and FD&C Blue #1.

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  • INDICATIONS & USAGE

    INDICATIONS: PRENATE ® PIXIE 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.

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  • CONTRAINDICATIONS

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

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  • PRECAUTIONS

    PRECAUTIONS: 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 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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  • ADVERSE REACTIONS

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

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  • DOSAGE & ADMINISTRATION

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

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  • HOW SUPPLIED

    HOW SUPPLIED: Bottles of 30 softgels (75854-0316-30). 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.

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  • 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.]

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  • SPL UNCLASSIFIED SECTION

    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.

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

    MANUFACTURED FOR:
    Avion Pharmaceuticals, LLC
    Alpharetta, Georgia 30022
    1-888-61-AVION

    Rev. 1014

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 softgel container image

    75854-0316-30

    Prenate® pixie

    Robust Rx Prenatal Vitamin with
    11 concentrated nutrients and minerals
    in a tiny softgel package

    GLUTEN FREE

    R x Only

    Prenatal Supplement

    30 Softgels

    Avion
    PHARMACUETICALS

    PRINCIPAL DISPLAY PANEL - 30 softgels
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  • INGREDIENTS AND APPEARANCE
    PRENATE PIXIE 
    ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-316
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 30 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 75 ug
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 500 [iU]
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 13 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 400 ug
    FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 10 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 150 ug
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 5 mg
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 200 mg
    BLUEBERRY (UNII: 253RUG1X1A) (BLUEBERRY - UNII:253RUG1X1A) BLUEBERRY 5 mg
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 600 ug
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CORN OIL (UNII: 8470G57WFM)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color purple Score no score
    Shape OVAL Size 22mm
    Flavor Imprint Code PIX
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75854-316-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/14/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/14/2014
    Labeler - Avion Pharmaceuticals, LLC (965450542)
    Establishment
    Name Address ID/FEI Business Operations
    Avion Pharmaceuticals, LLC 965450542 manufacture(75854-316)
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