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
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Drug Label Information
Updated January 22, 2024
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- SPL UNCLASSIFIED SECTION
- DESCRIPTION
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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
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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.
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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 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?)
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
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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
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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
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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 coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-313 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 40 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 90 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 220 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 10 [iU] PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 26 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 400 ug 5-METHYLTETRAHYDROFOLIC ACID (UNII: TYK22LML8F) (5-METHYLTETRAHYDROFOLIC ACID - UNII:TYK22LML8F) 5-METHYLTETRAHYDROFOLIC ACID 600 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 13 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 280 ug CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 155 mg FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 18 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 150 ug MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 50 mg DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 300 mg Inactive Ingredients Ingredient Name Strength 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 Color green, yellow (opaque) Score no score Shape OVAL Size 24mm Flavor Imprint Code Prenate Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75854-313-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/18/2014 Labeler - Avion Pharmaceuticals, LLC (040348516) Establishment Name Address ID/FEI Business Operations Avion Pharmaceuticals, LLC 040348516 manufacture(75854-313)