OMEGA3 FISH OIL capsule, gelatin coated

Omega3 Fish Oil by

Drug Labeling and Warnings

Omega3 Fish Oil by is a Other medication manufactured, distributed, or labeled by Regimed Medical, Procaps S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Softgel	Servings 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

STATEMENT OF IDENTITY

Omega-3 Fish Oil

INGREDIENTS AND APPEARANCE

OMEGA3 FISH OIL 
omega3 fish oil capsule, gelatin coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:25685-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F)	FISH OIL	1000 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:25685-100-01	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		12/16/2021

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	23 mm
scoring	1

Labeler - Regimed Medical (809916570)

Registrant - Regimed Medical (809916570)

Establishment
Name	Address	ID/FEI	Business Operations
Procaps S.A.		883237850	manufacture(25685-100)