Label: OVEEZA- folic acid, methylcobalamin, alpha lipoic acid, ubidecarenone, omega-3 fatty acids, icosapent, and doconexent capsule, liquid filled
- NHRIC Code(s): 73480-404-30
- Packager: TriVue Pharmaceuticals, Inc.
- Category: DIETARY SUPPLEMENT
Drug Label Information
Updated May 6, 2020
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- HEALTH CLAIM
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STATEMENT OF IDENTITY
TriVue Pharmaceuticals does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.† This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). 1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.1. Federal Register Notice of August 2, 1973 (38 FR 20750)2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044) 3. Federal Register Notice of March 5, 1996 (61 FR 8760)
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- HEALTH CLAIM
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WARNINGS AND PRECAUTIONS
PRECAUTION
Use with caution in patients that may have a medical condition, planning surgery, have bleeding problems,are pregnant, lactating, trying to conceive, under the age of 18, or taking other medications. 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. Oveeza Softgels should only be used under the direction and supervision of a licensed medical practitioner. Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA and EPA) 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.
Potential for Allergic Reactions in Patients with Fish Allergy: It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to products containing omega-3 fatty acid ethyl esters, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), derived from fish oil. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to Oveeza and advise them to discontinue and seek medical attention if any reactions occur.
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- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
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DOSAGE & ADMINISTRATION
Supplement Facts Serving Size: 2 Softgels Servings per Bottle: 15 Amount Per Serving %Daily Value - *
- Daily Values (DV) not established.
Folate (as folic acid) 1,667 mcg DFE
(1 mg Folic Acid)417% Vitamin B12 (as methylcobalamin) 500 mcg 20,834% Alpha Lipoic Acid (ALA) 100 mg * CoEnzyme Q-10 (ubiquinone) 100 mg * Total Omega-3 Fatty Acids 1125 mg * Eicosapentaenoic Acid (EPA) 600 mg Docosahexaenoic Acid (DHA) 450 mg OTHER INGREDIENTS Lecithin, Beeswax, Gelatin (Bovine), Glycerin, Annatto Ext, Titanium Dioxide, Purified water. CONTAINS: Fish and Soy.
- PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
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INGREDIENTS AND APPEARANCE
OVEEZA
folic acid, methylcobalamin, alpha lipoic acid, ubidecarenone, omega-3 fatty acids, icosapent, and doconexent capsule, liquid filledProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:73480-404 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 0.5 mg METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 250 ug ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y) (ALPHA LIPOIC ACID - UNII:73Y7P0K73Y) ALPHA LIPOIC ACID 50 mg UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE 50 mg OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 563 mg ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 300 mg DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 225 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) Yellow Wax (UNII: 2ZA36H0S2V) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) ANNATTO (UNII: 6PQP1V1B6O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:73480-404-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 04/30/2020 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 16 mm imprint Labeler - TriVue Pharmaceuticals, Inc. (114003376)
