ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
WALGREEN CO.

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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 and ethyl acrylate 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)


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MADE IN INDIA


Code: TS/DRUGS/22/2009 

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

MAY TAKE 1 TO 4 DAYS                                      Walgreens
FOR FULL EFFECT
                                                        NDC 0363-0508-05
ACID REDUCER
Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
CAPSULES    24 HOUR
Treats frequent heartburn
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)

Walgreens                                                                       Compare to
                                                                                        Nexiumr® 24HR
                                                                                        active ingredient
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT          NDC 0363-0508-05

ACID REDUCER
Esomeprazole
Magnesium

DELAYED-RELEASE CAPSULES USP 20 mg*
CAPSULES    24 HOUR
Treats frequent heartburn  
14 CAPSULES                                                              ACTUAL SIZE
 ONE 14-DAY COURSE OF TREATMENT                 SEE NEW WARNING INFORMATION

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


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

Walgreens                                                                                        Compare to Nexium® 24HR
                                                                                                           active ingredient
    
MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
                                                                                                                                NDC 0363-0508-08
ACID REDUCER
Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
CAPSULES    24 HOUR
Treats frequent heartburn  
28 CAPSULES                                                                ACTUAL SIZE
TWO 14-DAY COURSE OF TREATMENT                  SEE NEW WARNING INFORMATION    

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

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

Walgreens                                                                            Compare to Nexium® 24HR
                                                                                             active ingredient

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
                                                                                                                                NDC 0363-0508-10
ACID REDUCER
Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
CAPSULES    24 HOUR
Treats frequent heartburn  
42 CAPSULES                                                                 ACTUAL SIZE
THREE 14-DAY COURSES OF TREATMENT              SEE NEW WARNING INFORMATION    


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Capsule Container Carton)
ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0508
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 AND ETHYL ACRYLATE COPOLYMER (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:0363-0508-051 in 1 CARTON10/16/2017
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0363-0508-082 in 1 CARTON10/16/2017
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0363-0508-103 in 1 CARTON10/16/2017
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20933910/16/2017
Labeler - WALGREEN CO. (008965063)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(0363-0508) , MANUFACTURE(0363-0508)

Revised: 11/2021
Document Id: 29aed9f9-d2e5-4c4d-b76b-2673e7f12a92
Set id: f9e10472-c6a3-402c-b6a2-f8700ad73e9f
Version: 9
Effective Time: 20211124
 
WALGREEN CO.