ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
Amerisource Bergen

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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 Amerisource Bergn
1300 Morris Drive, Chesterbrook, PA 19087
Questions or Concerns?       
www.mygnp.com

Made in India
Code: TS/DRUGS/22/2009


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

Rx
GOOD                         NDC 46122-538-74                        
NEIGHBOR                                      
PHARMACY®
                                      
                                                        24 HR
Esomeprazole Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn         Capsules
May take 1 to 4 days for full effect    
14 Capsules  |one 14-day course  of treatment

esomeprazole-fig1.jpg


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

Rx
GOOD                                                Compare to Nexium® 24 HR
NEIGHBOR                                       active ingredient**
PHARMACY®
                                  NDC 46122-538-74
See new warning information                24 HR
Esomeprazole
Magnesium

delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn
May take 1 to 4 days for full effect           actual
14                    Capsules                         size
Capsules
 |     one 14-day course
                        of treatment



esomeprazole-fig2.jpg

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

Rx
GOOD
NEIGHBOR                                  Compare to Nexium® 24 HR  active ingredient**
PHARMACY®                               NDC 46122-538-03
See new warning information              24 HR
Esomeprazole Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn
May take 1 to 4 days for full effect     Capsules      actual
                                                                                size
28 Capsules | two 14-day courses
(2 bottles of 14 each) | of treatment

esomeprazole-fig3.jpg



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

Rx
GOOD
NEIGHBOR             Compare to Nexium® 24 HR  active ingredient**
PHARMACY®         NDC 46122-538-04
See new warning information              24 HR
Esomeprazole Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn
May take 1 to 4 days for full effect     Capsules      actual
                                                                                  size
42 Capsules                | three 14-day courses of treatment
(3 bottles of 14 each)

esomeprazole-fig4.jpg


ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-538
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:46122-538-741 in 1 CARTON10/16/2017
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:46122-538-032 in 1 CARTON10/16/2017
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:46122-538-043 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 - Amerisource Bergen (007914906)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(46122-538) , MANUFACTURE(46122-538)

Revised: 3/2021
Document Id: 4516feac-4648-4b64-ba75-fc45bf554bb8
Set id: 883c6967-9b25-41cc-af53-526a0517bfb4
Version: 4
Effective Time: 20210311
 
Amerisource Bergen