ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
Publix

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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.

 DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKEAND, FL 33811
1-888-267-3037 publix.com
MADE IN INDIA

PUBLIX GURANTEE: COMPLETE SATISFACTION
OR YOUR MONEY BACK

Code: TS/DRUGS/22/2009

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

24 HR              NDC 56062-020-06
esomeprazole
magnesium
DELAYED-RELEASE CAPSULES USP 20 mg
ACID REDUCER

•  Treats frequent heartburn   •  May take 1 to 4 days for full effect
•  One 14-day course of treatment

 14 CAPSULES



esomeprazole-fig1.jpg

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

SEE NEW                                         NDC 58602-020-06
WARNINGS                 24 HR
INFORMATION

esomeprazole
magnesium
DELAYED-RELEASE CAPSULES
USP 20 mg
ACID REDUCER

•Treats frequent heartburn

•May take 1 to 4 days for full effect
•One 14-day course of treatment

ACTUAL SIZE

14 CAPSULES

Compare to Nexium® 24 HR
active ingredient
esomeprazole-fig2.jpg

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-020
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:56062-020-061 in 1 CARTON03/30/2020
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:56062-020-082 in 1 CARTON03/30/2020
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:56062-020-103 in 1 CARTON03/30/2020
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20933903/30/2020
Labeler - Publix (006922009)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(56062-020) , MANUFACTURE(56062-020)

Revised: 3/2021
Document Id: 0b784283-ec4a-45db-86b3-097e4fdb2a8a
Set id: c45fd180-9d81-41e0-b7f8-025b8f29763a
Version: 3
Effective Time: 20210312
 
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