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

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Esomeprazole Magnesium Delayed-Release Tablets 20 mg*

Drug Facts

Active ingredient (in each tablet)


*Esomeprazole 20 mg
(Each film-coated delayed-release tablet 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.
■ Esomeprazole may cause severe skin reactions.
   Symptoms may include:
   ■  skin reddening ■  blisters ■  rash
If an allergic reaction occurs, stop use and seek medical help right away.

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, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, 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)

Tips for Managing Heartburn

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

♥CVSHealth®

NDC 51316-088-01

Treats Frequent Heartburn
May take 1 to 4 days for full effect                            24
Esomeprazole                                                            HOUR
Magnesium
DELAYED-RELEASE TABLETS 20 mg*

Acid reducer

14 TABLETS
One 14-day course of treatment


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

♥CVSHealth®

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

NDC 51316-088-01

Treats Frequent Heartburn                             24

May take 1 to 4 days for full effect                HOUR

Esomeprazole
Magnesium
DELAYED-RELEASE
TABLETS 20 mg*

Acid reducer

See new warning
information

14
TABLETS
(1 bottle inside)
One 14-day course
of treatment                            Actual Size

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-088
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)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
HYDROXYPROPYL CELLULOSE (20000 WAMW) (UNII: KZQ570MOA5)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW) (UNII: 7773C1ROEU)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
MICROCRYSTALLINE CELLULOSE 301 (UNII: W7YXH6D4BD)  
MICROCRYSTALLINE CELLULOSE 302 (UNII: 91B875MM4H)  
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
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
ColorPINK (Light pink) Scoreno score
ShapeOVAL (Oblong, Biconvex) Size13mm
FlavorImprint Code K;12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-088-011 in 1 CARTON07/04/2024
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51316-088-053 in 1 CARTON07/04/2024
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21447307/04/2024
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(51316-088) , MANUFACTURE(51316-088)

Revised: 7/2024
Document Id: c7b8460b-d1da-41d9-b644-157718295382
Set id: 1867185e-9c34-c8cc-e063-6394a90ab3b1
Version: 2
Effective Time: 20240709
 
CVS Pharmacy, Inc.