Keep VIMOVO dry.

Keep VIMOVO and all medicines out of the reach of children.

General information about VIMOVO

Medicines are sometimes prescribed for purposes other than those listed in this Medication Guide. Do not use VIMOVO for a condition for which it was not prescribed. Do not give VIMOVO to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about VIMOVO. If you would like more information, ask your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.

For more information, call 1-800-236-9933 or go to www.VIMOVO.com

What are the ingredients in VIMOVO?

Active ingredients: naproxen and esomeprazole magnesium

Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, glyceryl monostearate, hypromellose, iron oxide black, magnesium stearate, methacrylic acid copolymer dispersion, methylparaben, polysorbate 80, polydextrose, polyethylene glycol, povidone, propylene glycol, propylparaben, titanium dioxide, and triethyl citrate.

Distributed by: AstraZeneca LP, Wilmington, DE 19850

Issued June 2011

This Medication Guide has been approved by the U.S. Food and Drug Administration.

VIMOVO is a trademark of the AstraZeneca group of companies.

Other trademarks are the property of their respective companies.

PACKAGE LABEL - VIMOVO 375 / 20 MG TABLET

VIMOVO
naproxen and esomeprazole magnesium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-957(NDC:0186-0510)
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN)  NAPROXEN 375mg
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE)  ESOMEPRAZOLE MAGNESIUM 20mg
 
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE YELLOW 
GLYCERYL MONOSTEARATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
METHACRYLIC ACID 
METHYLPARABEN 
POLYSORBATE 80 
POLYETHYLENE GLYCOL 
POVIDONE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
FERROSOFERRIC OXIDE 
POLYDEXTROSE 
 
Product Characteristics
Color yellow (FILM-COATED)  Score no score 
Shape OVAL Size 17mm
Flavor  Imprint Code 375;20 
Contains 
 
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-957-30 30 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
2 NDC:16590-957-60 60 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
3 NDC:16590-957-90 90 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022511 07/01/2011 

Labeler -STAT RX USA LLC (786036330) 
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC  786036330 relabel,repack