Label: PRENATE PIXIE- ascorbic acid, biotin, cholecalciferol, cyanocobalamin, levomefolate calcium, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docosahexaenoic acid, and blueberry tablet, film coated
- NDC Code(s): 75854-316-30
- 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 May 14, 2025
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DESCRIPTION
Rx Only Dietary Supplement
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”. Prenate Pixie ®contains no ingredient made from gluten-containing grain (wheat, barley, or rye)
- INDICATIONS & USAGE
- CONTRAINDICATIONS
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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.
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PRECAUTIONS
PRECAUTIONS:Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin. - BOXED WARNING (What is this?)
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
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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.
- STORAGE AND HANDLING
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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.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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.
MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30005
1-888-61-AVIONL-0244 Rev. 0325-03
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRENATE PIXIE
ascorbic acid, biotin, cholecalciferol, cyanocobalamin, levomefolate calcium, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docosahexaenoic acid, and blueberry tablet, film coatedProduct 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 12.5 ug 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- 4.5 mg BLUEBERRY (UNII: 253RUG1X1A) (BLUEBERRY - UNII:253RUG1X1A) BLUEBERRY 5 mg DOCOSAHEXAENOIC ACID (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCOSAHEXAENOIC ACID 200 mg LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 600 ug Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) CARAMEL (UNII: T9D99G2B1R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) BEESWAX (UNII: 2ZA36H0S2V) PALM SHORTENING (UNII: 5QUO05548Z) 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 08/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/15/2014 Labeler - Avion Pharmaceuticals, LLC (040348516)
