ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release 
Thirty Madison Inc

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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

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 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

  • warfarin, clopidogrel or cilostazol (blood-thinning medicines)
  • prescription ant fungal or anti-yeast medicines
  • digoxin (heart medicine)
  • diazepam (anxiety medicine)
  • tacrolimus or mycophenolate mofetil (immune system medicine)
  • prescription antiretrovirals (medicines for HIV infection)
  • methotrexate (arthritis medicine)

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.

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 8 AM to 10 PM EST at 1-888-375-3784

Tips for Managing Heartburn

Container Label

Container Label:

Bottle

Carton label

Carton

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71713-202
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT) Esomeprazole 20 mg
Inactive Ingredients
Ingredient Name Strength
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 - Ethyl Acrylate Copolymer (1:1) Type A (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
Color BLUE (light blue cap) , BLUE (dark blue body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code RDY;327
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71713-202-01 1 in 1 CARTON 05/31/2019
1 14 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:71713-202-03 3 in 1 CARTON 05/31/2019
2 14 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207673 05/31/2019
Labeler - Thirty Madison Inc (080774087)

Revised: 9/2018
Document Id: 277a1c13-e5dc-71a8-5d5c-4b853d8870d0
Set id: ecf8010c-3ed7-838b-d500-1a0e1dce3e94
Version: 2
Effective Time: 20180921
 
Thirty Madison Inc