ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium tablet, delayed release 
Dr. Reddys Laboratories Inc

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Drug Facts

Active ingredient(in each tablet)

*Esomeprazole 20 mg

(Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate, USP)  

Purpose

Acid reducer

Uses

Warnings

Allergy alert:

Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

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 lightheadness·

  • 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

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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

Storage

Inactive ingredients

crospovidone, glyceryl monostearate, hypromellose, iron oxide red, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polysorbate 80, simethicone, sodium stearyl fumarate, sugar spheres (contains sucrose and maize starch), talc, titanium dioxide, triethyl citrate

Questions or comments?

call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

Tips for Managing Heartbun

Distributor:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Issued: 10/2023

Principal Display Panel

Container label 14count:

container

Carton 14's count:

carton

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-069
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT) Esomeprazole20 mg
Inactive Ingredients
Ingredient NameStrength
Crospovidone (UNII: 2S7830E561)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Hypromelloses (UNII: 3NXW29V3WO)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Magnesium Stearate (UNII: 70097M6I30)  
Mannitol (UNII: 3OWL53L36A)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Dimethicone 350 (UNII: 2Y53S6ATLU)  
Sodium Stearyl Fumarate (UNII: 7CV7WJK4UI)  
Sucrose (UNII: C151H8M554)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Triethyl Citrate (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorPINK (light pink) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code I
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-069-423 in 1 CARTON12/30/2023
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21157112/30/2023
Labeler - Dr. Reddys Laboratories Inc (802315887)
Establishment
NameAddressID/FEIBusiness Operations
Reed Lane Inc001819879pack(43598-069)

Revised: 1/2024
Document Id: 47b2745a-5057-bba7-e1ab-eae5b8c75cc3
Set id: b9605af1-a117-2fea-9f4b-bd4816d804e2
Version: 1
Effective Time: 20240112
 
Dr. Reddys Laboratories Inc