ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
Family Dollar Stores, 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.
■ 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, 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)

DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

Made in India

Code: TS/DRUGS/22/2009

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

FAMILY
Wellness

ESOMEPRAZOLE
MAGNESIUM
Delayed-Release Capsules USP, 20 mg*
Acid Reducer                                                               24
                                                                                HOUR
Treats Frequent Heartburn                                 CAPSULES
May take 1 to 4 days for full effect

14 CAPSULES
ONE 14-DAY COURSE OF TREATMENT

NDC 55319-051-05
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label)


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

FAMILY
Wellness
See new warning information
COMPARE TO
NEXIUM® 24 HR
ACTIVE INGREDIENT


ESOMEPRAZOLE
MAGNESIUM                                                            24
Delayed-Release Capsules USP, 20 mg*               HOUR

Acid Reducer
Treats Frequent Heartburn


May take 1 to 4 days for full effect

14 CAPSULES                                                    ACTUAL SIZE    
ONE 14-DAY COURSE OF TREATMENT

NDC 55319-051-05
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)

       

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-051
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:55319-051-051 in 1 CARTON08/17/2023
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55319-051-033 in 1 CARTON08/17/2023
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20933908/17/2023
Labeler - Family Dollar Stores, LLC (024472631)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(55319-051) , MANUFACTURE(55319-051)

Revised: 8/2023
Document Id: e77b6ffb-9021-4520-93c1-20cf697ff1bd
Set id: f86ba9b5-736e-b279-e053-6394a90acf7c
Version: 2
Effective Time: 20230818
 
Family Dollar Stores, LLC