FDA.reportPublic FDA data

Ultra Omega 3

Manufacturer
Liberty Bioscience LLC | United Pharma, LLC.
Effective date
2017-05-01
Label type
DIETARY SUPPLEMENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:48:29

Label at a glance#

ProductUltra Omega 3
Active ingredientIcosapent, Doconexent, FISH OIL
Label structure6 sections

Dosage and administration

Take 1 or 2 softgel daily, or as directed by a physician.

Label contents#

Full prescribing information#

Supplement Facts

STATEMENT OF IDENTITY SECTION

Dietary Supplement

Serving Size: 1 Softgel

Servings Per Container: 100

Amount Per Serving% Daily Value
Calories10
  Calories from Fat10
Total Fat1 g2%*
Saturated Fat0.5 g3%
Fish body oil
  EPA (eicosapentaenoic acid) 300 mg
  DHA (docosahexaenoic acid) 200 mg 		1,000 mg* †

* Percent Daily Values are based on a 2,000 calorie diet.

† Daily value not established.

Other ingredients: Gelatin, glycerin, Purified Water, Vitamin E

Contains fish (mackerel, sardines, anchovy)

Directions

DOSAGE & ADMINISTRATION SECTION

Take 1 or 2 softgel daily, or as directed by a physician.

Warning

WARNINGS SECTION

If you are pregnant, nursing, taking any medications or have any medical condition, consult your doctor before use.

SAFE HANDLING WARNING SECTION

  • Keep out of the reach of children.
  • Store at 15-30°C (59-86°F).
  • Protect from heat, light and moisture.
  • Do not purchase if seal is broken.

Distributed By:
Liberty BioScience™
401 E. 80th Street
Suite 8B
New York, NY, 10075

HEALTH CLAIM SECTION

Help Support: Healthy Joints, Healthy Cholesterol

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULTRA OMEGA 3™

EPA 300 / DHA 200 FORMULA

COLD WATER, DEEP SEA, FISH OIL

ESSENTIAL FATTY ACIDS

MERCURY FREE

100 Softgels

Dietary Supplement

Principal Display Panel - 100 Softgel Label
Principal Display Panel - 100 Softgel Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021
cd2aa2bf-3a9a-4fb3-9436-a62d0a299fa7Product name120230823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71410-100-01Ultra Omega 3100 in 1 BOTTLECAPSULE, GELATIN COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71410-100ULTRA OMEGA 3 (ICOSAPENT, DOCONEXENT, AND OMEGA-3 FATTY ACIDS) CAPSULE, GELATIN COATED [LIBERTY BIOSCIENCE LLC]31 package rows20170530_35d197e8-47c3-4fe7-98b6-e462b8cfb7e4.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71410-10071410-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
IcosapentAAN7QOV9EAACTIB
DoconexentZAD9OKH9JCACTIB
FISH OILXGF7L72M0FACTIB
Gelatin2G86QN327LIACT
glycerinPDC6A3C0OXIACT
tocopherolR0ZB2556P8IACT
mackerel, unspecifiedCYO6K3VM7FIACT
sardine, unspecified81PL60N4UAIACT
anchovy, unspecified025ZB55O8NIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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