ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release 
Dr. Reddy's Laboratories Inc

----------

Drug Facts

Active ingredient(s) in each capsule

*Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)

Purpose

Acid reducer

Use(s)

Warnings

Allergy alert:

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

  • 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

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

acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1,  ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide

Questions or comments

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

Tips for Managing Heartburn

Revised: 09/2022

Carton label

Container Carton Label - 14s Count

Carton

Bottle label

Container Label - 14s Count

Bottle

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-407
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT) Esomeprazole20 mg
Inactive Ingredients
Ingredient NameStrength
acetyltributyl citrate (UNII: 0ZBX0N59RZ)  
Dibutyl Sebacate (UNII: 4W5IH7FLNY)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Gelatin (UNII: 2G86QN327L)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Hypromelloses (UNII: 3NXW29V3WO)  
Magnesium Oxide (UNII: 3A3U0GI71G)  
Magnesium Stearate (UNII: 70097M6I30)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
Poloxamer 188 (UNII: LQA7B6G8JG)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Povidone K30 (UNII: U725QWY32X)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Shellac (UNII: 46N107B71O)  
Sucrose (UNII: C151H8M554)  
Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUE (light blue cap) , BLUE (dark blue body) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code RDY;327
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-407-521 in 1 CARTON05/16/2018
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:43598-407-272 in 1 CARTON05/16/2018
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:43598-407-333 in 1 CARTON05/16/2018
314 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:43598-407-742 in 1 CARTON05/16/2018
4NDC:43598-407-707 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20767305/16/2018
Labeler - Dr. Reddy's Laboratories Inc (802315887)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Limited - FTO 3918608162analysis(43598-407) , manufacture(43598-407)

Revised: 9/2022
Document Id: 1f7dc391-028d-a98f-7cc6-887f293caf06
Set id: cb8297ad-ce1b-aa31-2488-5a38b2dbc774
Version: 9
Effective Time: 20220930
 
Dr. Reddy's Laboratories Inc