ESOMEPRAZOLE- esomeprazole magnesium tablet 
HARRIS TEETER

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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

Use

treats frequent heartburn (occurs 2 or more days a week)
not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

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

adults 18 years of age and older
this product is to be used once a day (every 24 hours), every day for 14 days
may take 1 to 4 days for full effect
14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning
take every day for 14 days
do not take more than 1 capsule a day
swallow whole. Do not crush or chew capsules.
do not use for more than 14 days unless directed by your doctor
 
Repeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months
do not take for more than 14 days or more often than every 4 months unless directed by a doctor
children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Other information

read the directions and warnings before use.
Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.]
keep the carton. It contains important 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?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

PROUDLY DISTRIBUTED BY:
HARRIS TEETER, LLC
MATTHEWS, NC 28105

R0320

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton

Compare To Nexium® 24HR

NDC 72036-982-42

Harris Teeter
Three 14-day courses of treatment
May take 1 to 4 days for full effect

ESOMEPRAZOLE
MAGNESIUM
Delayed-Release Capsules USP,
20 mg* / ACID REDUCER
Treats FREQUENT Heartburn
24 HR

ACTUAL SIZE

3 x 14 Count Bottles Inside

42
CAPSULES

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton
ESOMEPRAZOLE 
esomeprazole magnesium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72036-982
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 AND ETHYL ACRYLATE COPOLYMER (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
ShapeOVALSize14mm
FlavorImprint Code RG;50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72036-982-423 in 1 CARTON03/03/2021
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21286603/03/2021
Labeler - HARRIS TEETER (047279351)
Registrant - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(72036-982)

Revised: 4/2021
Document Id: 97ef0c76-1b40-4263-9ec0-eba9a9f3d454
Set id: ea9ef7b0-7397-470f-b852-397e8b0e66e4
Version: 3
Effective Time: 20210430
 
HARRIS TEETER