Omega3 Fish Oil

Manufacturer
Regimed Medical | Procaps S.A.
Effective date
2021-12-16
Label type
Dietary Supplement
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:17

Label at a glance#

ProductOmega3 Fish Oil
Active ingredientFISH OIL
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 25685-0100-01

OMEGA-3 FISH OIL

300 mg EPA

200 mg DHA

FORMULA

100 Softgels

DIETARY SUPPLEMENT

Supplement Facts
Serving Size: 1 SoftgelServings Per Container: 100 
Amount Per Serving% Daily Value
 Calories 10
   Calories from Fat 10
 Total Fat 1 g 1% †
 Fish oil Concentrate 1000 mg † †
    Elcosapentaenoic Acid (EPA) 300 mg † †
    Docosahexaenoic Acid (DHA) 200 mg † †
 † Percent Daily Values are based on a 2000 calorie diet.  
 †† Daily Value not established. 

OTHER INGREDIENTS: Gelatin, Glycerin, Purified Water, Vitamin E (mixed tocopherols) 

CONTAINS: Fish (anchovies, mackerel, sardines).

Directions: Take one Softgel daily or as recommended by a physician.

WARNING: If you are pregnant, nursing, taking any medications or have any medical condition, consult your doctor before use. Discontinue use and consult your doctor if any adverse reaction occur.

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

Manufactured by:

PROCAPS S.A.

Distributed by:

REGIMED MEDICAL

labellabel

Statement of Identity section

Omega-3 Fish Oil

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd2aa2bf-3a9a-4fb3-9436-a62d0a299fa7Product name120230823
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25685-100-01Omega3 Fish Oil100 in 1 BOTTLECAPSULE, GELATIN COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25685-100OMEGA3 FISH OIL CAPSULE, GELATIN COATED [REGIMED MEDICAL]11 package rows20211222_0160e8f5-0ae9-4ec6-8d01-893e131f78ac.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
25685-10025685-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmegavenFISH OILFresenius Kabi USA, LLC5d9d0b24-e139-48bf-ab2d-536fb59cf8e02025-09-05Warnings, Adverse reactionsName fallback
generic name: FISH OIL

Reported adverse events (FAERS/openFDA)#

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