Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release

*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 may include:

·         skin reddening

·         blisters

·         rash

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

• 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.

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

FD&C blue 1, FD&C red 3, FD&C red 40, ferroso  ferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di-glycerides, polysorbate 80, potassium hydroxide, shellac, sodium lauryl sulfate, sugar spheres (contains corn starch, sucrose), talc, titanium dioxide, triethyl citrate

Call 1-800-883-3540 (Monday - Friday 8 am - 4 pm)

Tips of Managing Heartburn

• 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.

Do not use if seal under bottle cap imprinted with “SEALED FOR YOUR PROTECTION” or blue band around the center of each capsule is broken or missing.

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.  

NDC 53041-666-07

See new warning information

Esomeprazole Magnesium

Delayed-Release Capsules USP, 20 mg*

Acid Reducer

Treats Frequent Heartburn

24 HR Capsules

May take 1 to 4 days for full effect

14 CAPSULES - One 14-day course of treatment