ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
Retail Business Services, LLC.

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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: FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
PRODUCT OF INDIA
1-877-846-9949
© 2019 Ahold Delhaize Licensing Sàrl
Quality guaranteed or your money back.
Code: TS/DRUGS/22/2009



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

CAREone®
NDC 72476-500-05
ESOMEPRAZOLE MAGNESIUM
Delayed-Release Capsules USP 20 mg*
Acid Reducer
24 hr

Treats Frequent Heartburn
May take 1 to 4 days for full effect
One 14-day
course of treatment
14 CAPSULES



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

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

CAREone®
NDC 72476-500-05
Compare to the active ingredient
in Nexium® 24 HR

See new warning Information
ESOMEPRAZOLE MAGNESIUM
Delayed-Release Capsules USP 20 mg*
Acid Reducer
24 hr
Treats Frequent Heartburn

May take 1 to 4 days for full effect
Capsules
Actual Size
14 CAPSULES
One 14-day course of treatment
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Carton)

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

CAREone®
NDC 72476-500-03
Compare to the active ingredient
in Nexium
® 24 HR 
See new warning information
ESOMEPRAZOLE MAGNESIUM
Delayed-Release Capsules USP
20 mg*
Acid Reducer
24 HR
Treats Frequent Heartburn
May take 1 to 4 days for full effect
Capsules
Actual size
42 CAPSULES
(3 bottles of 14 each)
Three 14-day courses of treatment

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:72476-500
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:72476-500-051 in 1 CARTON10/16/2017
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:72476-500-033 in 1 CARTON10/16/2017
214 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 - Retail Business Services, LLC. (967989935)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(72476-500) , MANUFACTURE(72476-500)

Revised: 3/2021
Document Id: 855f7fd6-0c28-4eea-8c9d-466d79782133
Set id: ce376d91-0ea8-4922-9f7f-707420cb1d96
Version: 5
Effective Time: 20210312
 
Retail Business Services, LLC.