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Esomeprazole Magnesium by Chain Drug Consortium, LLC

Dosage form: capsule, delayed release
Ingredients: ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-007

Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg*

Drug Facts

Active ingredient   (in each capsule) 


*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

Acid reducer

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

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 before use. Heartburn in children may sometimes be caused by a serious condition.

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F)
  • Meets USP dissolution test 2

Inactive ingredients

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.

Questions or comments?


call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)


Distributed By:  
Pharmacy Value Alliance LLC
407 East Lancaster Avenue, Wayne, PA 19087
MADE IN INDIA

Code: TS/DRUGS/22/2009             






PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label)

Premier Value®
Esomeprazole Magnesium
Delayed-Release Capsules 
 USP 20 mg*
Acid Reducer
24 HR

Treats Frequent Heartburn
May take 1 to 4 days for full effect
14 Capsules
One 14-day Course of treatment




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)

Premier Value®
#Compare to Nexium® 24 HR
Active ingredient
Esomeprazole Magnesium
Delayed-Release Capsules USP
20 mg*
Acid Reducer
24 HR
Treats Frequent Heartburn

May take 1 to 4 days for full effect 
14 Capsules
 One 14-day Course of treatment





       

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-007
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (ESOMEPRAZOLE) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C BLUE NO. 1 
GELATIN, UNSPECIFIED 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM CARBONATE 
MAGNESIUM OXIDE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
GLYCERYL MONOSTEARATE 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SHELLAC 
SODIUM LAURYL SULFATE 
AMMONIA 
DEXTROSE, UNSPECIFIED FORM 
STARCH, CORN 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeI81
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-007-141 BOTTLE in 1 CARTON
114 CAPSULE, DELAYED RELEASE in 1 BOTTLE
2NDC:68016-007-423 BOTTLE in 1 CARTON
214 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20933910/16/2017
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(68016-007), MANUFACTURE(68016-007)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited918917626API MANUFACTURE(68016-007)

 
Chain Drug Consortium, LLC

← See all Esomeprazole Magnesium brands

Medically reviewed on Jul 25, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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