Oveeza

Manufacturer
TriVue Pharmaceuticals, Inc.
Effective date
2020-05-06
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:36

Label at a glance#

ProductOveeza
Active ingredientFOLIC ACID, METHYLCOBALAMIN, ALPHA LIPOIC ACID, UBIDECARENONE, OMEGA-3 FATTY ACIDS, ICOSAPENT, DOCONEXENT
Label structure13 sections

Dosage and administration

Usual adult dose is 1-2 softgels once daily with a meal, or as prescribed by a licensed medical practitioner. Patients should be advised to swallow Oveeza Softgels whole. Do not break open, crush, dissolve, or chew Oveeza Softgels. Do Not Exceed the Recommended Dosage.

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

KEEP OUT OF REACH OF CHILDREN.

Manufactured for: TriVue Pharmaceuticals, Inc.Birmingham, AL 35235

This product is not an Orange Book product.
Dispensed by Prescription†
MADE IN CANADA
Rev. 04/2020*

STATEMENT OF IDENTITY SECTION

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)

Dosage

DOSAGE & ADMINISTRATION SECTION

Usual adult dose is 1-2 softgels once daily with a meal, or as prescribed by a licensed medical practitioner.If you are pregnant or nursing, ask a healthcare professional.

KEEP OUT OF REACH OF CHILDREN

STORAGE

HEALTH CLAIM SECTION

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

HEALTH CLAIM SECTION

Manufactured for: TriVue Pharmaceuticals, Inc.,Birmingham, AL 35235

MADE IN CANADA Rev. 04/2020

DESCRIPTION

STATEMENT OF IDENTITY SECTION

Oveeza Softgels is an orally administered prescription dietary supplement for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B, and Omega-3 supplementation, and maintenance of good health is needed.

CONTRAINDICATIONS

HEALTH CLAIM SECTION

Oveeza Softgels are contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS AND PRECAUTIONS

WARNINGS SECTION

PRECAUTION

PRECAUTIONS SECTION

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.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may at 1-844-487-4883 or the FDA by calling 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Usual adult dose is 1-2 softgels once daily with a meal, or as prescribed by a licensed medical practitioner. Patients should be advised to swallow Oveeza Softgels whole. Do not break open, crush, dissolve, or chew Oveeza Softgels. Do Not Exceed the Recommended Dosage.

HOW SUPPLIED

HEALTH CLAIM SECTION

Oveeza Softgels are available as brown, oblong softgels imprinted with "404" and are available in 30-count bottles (73480-404-30*).

STORAGE

HEALTH CLAIM SECTION

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture. Tamper Evident: Do not use if seal is broken or missing.

Oveeza Softgels - Dietary Supplement Dispensed by Prescription†

DOSAGE & ADMINISTRATION SECTION

Supplement Facts
Serving Size: 2 SoftgelsServings per Bottle: 15
Amount Per Serving%Daily Value
Folate (as folic acid)1,667 mcg DFE
(1 mg Folic Acid)
417%
Vitamin B12 (as methylcobalamin)500 mcg20,834%
Alpha Lipoic Acid (ALA)100 mg*
CoEnzyme Q-10 (ubiquinone)100 mg*
Total Omega-3 Fatty Acids1125 mg*
  Eicosapentaenoic Acid (EPA)600 mg
  Docosahexaenoic Acid (DHA)450 mg

* Daily Values (DV) not established.

OTHER INGREDIENTS Lecithin, Beeswax, Gelatin (Bovine), Glycerin, Annatto Ext, Titanium Dioxide, Purified water. CONTAINS: Fish and Soy.

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

73480-404-30

OVEEZA
Softgels

Dietary Supplement

Dispensed by Prescription

30 Softgels

TRIVUE
PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73480-404-30Oveeza30 in 1 BOTTLECAPSULE, LIQUID FILLED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73480-404OVEEZA (FOLIC ACID, METHYLCOBALAMIN, ALPHA LIPOIC ACID, UBIDECARENONE, OMEGA-3 FATTY ACIDS, ICOSAPENT, AND DOCONEXENT) CAPSULE, LIQUID FILLED [TRIVUE PHARMACEUTICALS, INC.]11 package rows20200512_36a5c22f-86a7-436a-bb1f-a925cd6940e4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73480-404-30EA - Each73480-4041ed40221-fd79-4155-9828-8bf94a965d1012020-06-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73480-40473480-404-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDREMEDYREPACK INC.bda4687e-929a-434d-ab59-909cf2ed73a22026-09-11Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDREMEDYREPACK INC.368b69a8-a021-47e3-a6d7-e3497d7363b12026-09-04Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDRising Pharma Holdings, Inc.0baa10dd-6d1d-4946-8236-566451132da32026-07-24Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDNorthwind Health Company, LLC03b0aee4-804a-de63-e063-6394a90a66352026-07-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDUnit Dose Solutions, Inc.54db8b21-87b9-5e0c-e063-6394a90ae8ea2026-06-22Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
VitramynFOLIC ACIDPureTek Corporationc8af7616-5178-6df0-e053-2a95a90a334d2026-06-18Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDCoupler LLC544e394d-3555-8ab1-e063-6394a90ade002026-06-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDMajor Pharmaceuticals7778ac96-7817-455a-a177-22ecb276c67f2026-05-26Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDQUAGEN PHARMACEUTICALS LLC354366ea-3702-4706-9fc0-0244b7278bd82026-05-20Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC624469a1-ded9-453a-973e-c5a2f0602bb02026-05-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC6dd867fe-597e-4915-8baf-98a605bf93242026-05-06Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepacka1b71c5d-c842-43fd-9557-2bb4e934b9142026-04-23Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDPreferred Pharmaceuticals Inc.b4c3a754-64cd-499a-a32f-a6e935c413552026-04-22Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmneal Pharmaceuticals of New York LLCfd85395e-6a0b-4072-a80b-36095c0c6dd62026-04-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
MultitamFOLIC ACIDPureTek Corporationcee15842-4a9e-c6ba-e053-2a95a90aebc52026-04-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDXGen Pharmaceuticals DJB, Inc.c5b2b84d-9f5e-4b81-ba10-9f2854e5dce92026-01-21Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC40ab3c91-5a5b-fa1d-e063-6394a90a74542025-12-10Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmerican Health Packagingfc6dc1e1-f63e-4239-a1eb-67525569f68c2025-11-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack4889d474-bd72-46ba-81d6-5511d8a85abb2025-11-04Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack41914ac8-f4f5-4d70-b9f2-9f88c59d67a62025-10-29Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.