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Esomeprazole

Medically reviewed by Drugs.com. Last updated on Nov 2, 2020.

Dosage form: capsule
Ingredients: ESOMEPRAZOLE MAGNESIUM 20mg
Labeler: Reliable 1 Laboratories
NDC Code: 69618-056

Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg* Acid Reducer

Drug Facts

Active ingredient (in each capsule)

*Esomeprazole 20 mg (Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)

Purpose

Acid reducer

Uses

treats frequent heartburn (occurs 2 or more days a week)

not intended for innediate 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 sings 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, particulary with heartburn

unexplained weight loss

nausea or vomiting

stomach pain

Ask a doctor or pharmacist before use if you are taking

warfarin, clopifogrel or cilostazol (blood-thinning medicines)

prescription antifungal or anti-yeast medications

digozin (heart medicine)

diazepam (anxiety medicine)

tacrolimus or mycophenolate mofetil (immune system medicines)

prescription antiretovirals (medicines for HIV infections)

methotrexate (arthritis medicine)

Stop use and ask a doctor if

your heartburn continues or worsens

you need to take this prodcut 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 prefessional before use

In case of overdose, get medical help or contract a Posion Control Center right away.

Directions

adults 18 years of age and older

this prodcut is to be used once a day (every 24 hours), every day for 14 days

make 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 of more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

you may repeart a 14-day course every 4 months

do not take for more than 14 days or more often than every 4 mounths unless directed by a doctor

children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be cuased by a serious condition.

Other Information

each capsule contains: magnesium, 15 mg

read the directions and warmings before use

keep the carton. It contains important information.

store at 20-25ºC (68 to 77ºF)

Inactive ingredients

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

Questions or comments?

call tool-free weekdays 8 AM to 10 PM EST at 1-888-375-3784

NDC 69618-056-42

Compare to the active ingredient in Nexium® 24 HR**

Esomeprazole Magnesium

Delayed-Release Capsules, USP

20 mg*

Acid Reducer

42 Capsules

Three 14-day Courses of Treatment

ESOMEPRAZOLE 
esomeprazole capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-056
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERYL MONOSTEARATE 
POLYSORBATE 80 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
POVIDONE 
POTASSIUM HYDROXIDE 
SHELLAC 
FD&C BLUE NO. 1 
MAGNESIUM OXIDE 
DIBUTYL SEBACATE 
FERROSOFERRIC OXIDE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
PROPYLENE GLYCOL 
POLOXAMER 188 
ACETYLTRIBUTYL CITRATE 
TITANIUM DIOXIDE 
SUCROSE 
TALC 
Product Characteristics
Coloryellow (Gelatin capsule shell with light blue cap and dark blue body) Scoreno score
ShapeOVAL (Capsule) Size9mm
FlavorImprint CodeRDY;327
Contains    
Packaging
#Item CodePackage Description
1NDC:69618-056-423 BOTTLE, PLASTIC in 1 CARTON
1NDC:69618-056-1414 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20767311/01/2018
Labeler - Reliable 1 Laboratories (079718111)

 
Reliable 1 Laboratories

Further information

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