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GENOZOL

Medically reviewed by Drugs.com. Last updated on Nov 12, 2021.

Dosage form: capsule, delayed release
Ingredients: ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20mg
Labeler: Genomma Lab USA Inc
NDC Code: 50066-923

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 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 

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)

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 1 877 99 GENOM (43666) (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by
Genomma Lab USA Inc., Houston, TX, 77027
Made in India
Code: TS/DRUGS/22/2009  

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

Genozol® 

Esomeprazole Magnesium / Magnesio de Esomeprazole
Delayed-Release Capsules USP 20 mg* /
Capsulas de liberacion prolongada USP 20 mg*

Acid Reducer / reductor de la acidez
Treats FREQUENT Heartburn!
May take 1 to 4 days for full effect

iAlivia el reflujo gastrico FRECUENTE!
Podria tardar entre 1 a 4 dias para lograr su accion completa

One 14-day courses of treatment  
Un tratamientos de 14 dias                      
                                                                               14 CAPSULES / CAPSULAS


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

See new warning information / Ver la nueva información de advertencias

Genozol® 

Esomeprazole Magnesium / Magnesio de Esomeprazole
Delayed-Release Capsules USP 20 mg* / Capsulas de liberacion prolongada USP 20 mg*

acid reducer / redutor de la acidez

Treats FREQUENT Heartburn!
May take 1 to 4 days for full effect

iAlivia el reflujo gastrico FRECUENTE!
Podria tardar entre 1 a 4 dias para lograr su accion complete

one 14-day course of treatment  
Un tratamiento de 14 dias                      
                                                                            14 CAPSULES / CAPSULAS





                                        

       

GENOZOL 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-923
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:50066-923-051 BOTTLE in 1 CARTON
114 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20933910/16/2017
Labeler - Genomma Lab USA Inc (832323534)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(50066-923), MANUFACTURE(50066-923)

 
Genomma Lab USA Inc

Further information

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