hat are not mentioned in patient information leaflets. Do not use LOVAZA for a condition for which it was not prescribed. Do not give LOVAZA to other people, even if they have the same problem you have. It may harm them.
This leaflet summarizes the most important information about LOVAZA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about LOVAZA that is written for health professionals or go to www.LOVAZA.com.
What are the ingredients in LOVAZA?
Active Ingredient: Omega-3-acid ethyl esters
Inactive Ingredients: Gelatin, glycerol, purified water, alpha-tocopherol (in partially hydrogenated vegetable oils, including soybean oil)
LOVAZA is a registered trademark of the GlaxoSmithKline group of companies.
PLAVIX is a registered trademark of Sanofi-Synthelabo.
Distributed by:
GlaxoSmithKline
Research Triangle Park, NC 27709
©2008 GlaxoSmithKline. All rights reserved.
June 2008 LVZ:1PIL
PRINCIPAL DISPLAY PANEL
NDC 0173-0783-01
Lovaza®
(omega-3-acid ethyl esters)
Capsules
60 Capsules
Rx only
Each capsule contains 1 gram omega-3-acid ethyl ester liquid concentrate consisting of at least 900 mg omega-3-acid ethyl esters.
Each capsule provides: Eicosapentaenoic acid (EPA) ethyl ester: 465 mg Docosahexaenoic acid (DHA) ethyl ester: 375 mg
Usual Dosage: See accompanying prescribing information.
Store at 25oC (77oF); excursions permitted to 15o-30oC (59o-86oF) [see USP Controlled Room Temperature]. Do not freeze.
Mfd for:
GlaxoSmithKline, RTP, NC 27709
Mfd by:
Catalent Pharma Solutions
St. Petersburg, FL 33716 or
Accucaps Industries, Ltd.
Windsor, ON, Canada N9C 3R5
Made in Norway
059191 Rev. 8/08
LOVAZA
omega-3-acid ethyl esters capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0173-0783
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) OMEGA-3-ACID ETHYL ESTERS 1 g
Inactive Ingredients
Ingredient Name Strength
ALPHA-TOCOPHEROL
GELATIN
GLYCERIN
WATER
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code REL900
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0173-0783-02 120 CAPSULE In 1 BOTTLE None
2 0173-0783-62 4 CAPSULE In 1 BOTTLE None
3 0173-0783-61 28 CAPSULE In 1 BOTTLE None
4 0173-0783-01 60 CAPSULE In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021654 10/21/2008
Labeler - SmithKline Beecham Corporation (167380711)
Revised: 07/2009SmithKline Beecham Corporation
