VIMOVO (Page 10 of 10)

PACKAGE LABEL — VIMOVO 375 / 20 MG TABLET

Label Image
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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 375 mg
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE MAGNESIUM 20 mg
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

Revised: 07/2011 STAT RX USA LLC

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