ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release 
Allegiant Health

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017 - ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Active ingredient(s)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer

Use(s)

  • 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 effe

Warnings

  • Do not use if you are allergic to esomeprazole.
  • Esomeprazole may cause severe skin reactions. Symptoms may include:
  • Skin reddening
  • Blisters
  • Rash

If an allergic reaction occurs, stop use and seek medical help right away.

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 lightheadedness
  • 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

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 breastfeeding,

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

  • 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 Repeated 14-Day Courses (if needed)

  • 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
  • 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° to 25°C (68° to 77°F).

Inactive ingredients

FD&C Blue 2, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion, Mono-and Di-Glycerides, Pharmaceutical Ink, Polysorbate 80, Sugar Spheres, Talc, Triethyl Citrate.

Questions/Comments

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST

Principal Display Panel

Esomeprazole 20 mg Label 42ct

Esomeprazole 20 mg Label 42ct

Esomeprazole 20 mg Carton 42ct

Esomeprazole 20 mg Carton 42ct

Esomeprazole 20 mg Label 14ct

Esomeprazole 20 mg Label 14ct

Esomeprazole 20 mg Carton 14ct

Esomeprazole 20 mg Carton 14ct

ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
RAW SUGAR (UNII: 8M707QY5GH)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 186;20mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-017-141 in 1 CARTON10/29/202401/29/2025
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69168-017-423 in 1 CARTON10/29/202401/29/2025
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21634910/29/202401/29/2025
Labeler - Allegiant Health (079501930)

Revised: 10/2024
 
Allegiant Health