ESOMEPRAZOLE- esomeprazole capsule, delayed release 
THE KROGER COMPANY

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esomeprazole

Drug Facts

Active ingredient (in each capsule)

*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer

Uses

Warnings

Allergy alert

Do not use if you are allergic to esomeprazole

Do not use if you have

  • trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • heartburn with lightheadedness, sweating or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
  • you need to take more than 1 course of treatment every 4 months
  • you get diarrhea
  • you develop a rash or joint pain

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

Other information

Inactive ingredients

FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.

Questions?

1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL - 24 Capsule Bottle Carton

COMPARE TO the active ingredient of
NEXIUM® 24HR **See bottom panel

NDC 30142-989-28

Kroger®

Esomeprazole
Magnesium

Delayed-release
Capsules USP,
20 mg*

ACID REDUCER

actual size

OUR PHARMACIST
RECOMMENDED

Treats Frequent Heartburn!

24 HR

28 CAPSULES

Two 14-Day Courses of Treatment

May Take 1 to 4 Days for Full Effect

PRINCIPAL DISPLAY PANEL - 24 Capsule Bottle Carton
ESOMEPRAZOLE 
esomeprazole capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-989
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code RG50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-989-282 in 1 CARTON08/07/2020
1NDC:30142-989-1414 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21286608/07/2020
Labeler - THE KROGER COMPANY (006999528)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(30142-989)

Revised: 10/2020
Document Id: d1f98f06-8779-4753-af5f-b45fffea3d92
Set id: 7fa75bbe-5b9f-49ca-84de-f80e5a858de4
Version: 3
Effective Time: 20201028
 
THE KROGER COMPANY