Esomeprazole Magnesium Capsule, Delayed Release
FDA Label NDC 79903-382

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

Acid Reducer

• 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

Allergy alert
• Do not use if you are allergic to esomeprazole
• Esomeprazole may cause severe skin reactions. Symptoms include:
o skin reddening
o blisters
o rash
If an allergic reaction occurs, stop use and seek medical attention right away.

• 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.

• 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

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.

• 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

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

• 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
o swallow 1 capsule with a glass of water before eating in the morning
o take every day for 14 days
o do not take more than 1 capsule a day
o swallow whole. Do not crush or chew capsules.
o do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
o you may repeat a 14-day course every 4 months
o 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.

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

black iron oxide, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Call 1-888-287-1915

• Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.

• Eat slowly and do not eat big meals.

• Do not eat late at night or just before bedtime.

• Do not lie flat or bend over soon after eating.

• Raise the head of your bed.

• Wear loose-fitting clothing around your stomach.

• If you are overweight, lose weight.

• If you smoke, quit smoking.