ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
Better Living Brands 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?

1-888-723-3929

BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929/www.betterlivingbrandsLLC.com

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

NDC XXXXX-XXX-XX
Capsules
Signature CareTM
Quality Guaranteed
24 Hours 
Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
Acid Reducer
Treats frequent heartburn                       14 Capsules
May take 1 to 4 days for full effect             One 14-day course of treatment



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

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

COMPARE TO Nexium® 24 HR
Active ingredient*

Capsules
1 Bottle Inside
NDC XXXXX-XXX-XX
Signature CareTM

Quality Guaranteed
24 Hours
Esomeprazole Magnesium
DELAYED-RELEASE CAPSULES USP 20 mg*
Acid Reducer
Treats frequent heartburn

May take 1 to 4 days for full effect
SEE NEW WARNING INFORMATION
14 Capsules
One 14-day course of treatment
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Carton Label)

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-100
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:21130-100-051 in 1 CARTON07/24/2019
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:21130-100-082 in 1 CARTON07/24/2019
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:21130-100-103 in 1 CARTON07/24/2019
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20933907/24/2019
Labeler - Better Living Brands LLC (009137209)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(21130-100) , MANUFACTURE(21130-100)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917626API MANUFACTURE(21130-100)

Revised: 11/2022
Document Id: 4505dba6-75e7-4ca5-9ca8-95384f093ddc
Set id: ee6e3f66-4eb9-4094-afcc-aaa020942b39
Version: 2
Effective Time: 20221104
 
Better Living Brands LLC