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

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Drug Facts

Active ingredient(s)

*Esomeprazole 20 mg

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

Purpose

Acid reducer

Use(s)

Warnings

Allergy alert: Do not use if you are allergic to esomeprazole

Do not use

  • 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

  • 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

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

Stop use and ask 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

· store at 20 to 25°C (68 to 77°F)

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

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: 0420

Principal Display Panel

Container 14's count:

container

Carton 14's count:

carton1

Carton 28s count

carton2

Carton 42s count

carton3

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-469
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 - Ethyl Acrylate Copolymer (1:1) Type A (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 469
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-469-521 in 1 CARTON11/15/2020
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:43598-469-282 in 1 CARTON11/15/2020
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:43598-469-423 in 1 CARTON11/15/2020
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21157111/15/2020
Labeler - Dr. Reddys Laboratories Inc (802315887)

Revised: 7/2020
Document Id: 3fb729ea-a04a-bfdd-d564-7045771e1247
Set id: 94e0d10a-4c72-4e58-abf7-cc00f7b90b23
Version: 5
Effective Time: 20200715
 
Dr. Reddys Laboratories Inc