ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
CVS Pharmacy, Inc.

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Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg*

Drug Facts

Active ingredient   (in each capsule) 


*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

Acid reducer

Uses

Warnings

Allergy alert: Do not use if you are allergic to esomeprazole

Do not use if you have:

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

    14-Day Course of Treatment

    Repeated 14-Day Courses (if needed)


Other information

Inactive ingredients

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.


Questions or comments?


call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, Rl 02895
©2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Label)

CVSHealthTM
Treats Frequent Heartburn
May take 1 to 4 days for full effect     24 HOUR

Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
Acid reducer
14 CAPSULES
One 14-day course of treatment
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Carton)

CVSHealthTM

Compare to the active
ingredient in Nexium® 24 HR**

Treats Frequent Heartburn
May take 1 to 4 days for full effect         24 HOUR

Esomeprazole Magnesium
DELAYED-RELEASE
CAPSULES USP 20 mg*

Acid reducer
See new warning information

14 CAPSULES
One 14-day Course
of treatment                 Actual Size
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Carton)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (28 Capsules Container Carton)

CVSHealthTM

Compare to the active

ingredient in Nexium® 24 HR**

Treats Frequent Heartburn
May take 1 to 4 days for full effect       24 HOUR

Esomeprazole Magnesium
DELAYED-RELEASE

CAPSULES USP 20 mg*

Acid Reducer
See new warning information

28 CAPSULES
(2 bottles of 14 each)
Two 14-day courses of treatment           Actual Size

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (28 Capsules Container Carton)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Capsules Container Carton)

CVSHealthTM

Compare to the active

ingredient in Nexium® 24 HR**

Treats Frequent Heartburn
May take 1 to 4 days for full effect     24 HOUR

Esomeprazole Magnesium
DELAYED-RELEASE
CAPSULES USP 20 mg*

Acid reducer
See new warning information

42 CAPSULES
(3 bottles of 14 each)
Three 14-day courses of treatment         Actual Size

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Capsules Container Carton)

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-248
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
AMMONIA (UNII: 5138Q19F1X)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code I81
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-248-061 in 1 CARTON07/09/2019
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69842-248-082 in 1 CARTON07/09/2019
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69842-248-103 in 1 CARTON07/09/2019
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20933907/09/2019
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(69842-248) , MANUFACTURE(69842-248)

Revised: 3/2021
Document Id: 9f5258ba-e377-4ef5-ad0e-4868eef60210
Set id: d226cda0-5cdb-4e2d-a865-530a8f09a095
Version: 5
Effective Time: 20210311
 
CVS Pharmacy, Inc.