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Esomeprazole Magnesium Delayed Release Capsules 


ACTIVE INGREDIENT(in each capsule)

*Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 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 effect 

WARNINGS

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.


DO NOT USE IF YOU HAVE

These may be signs of a serious condition. See your doctor.

  • 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

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 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.


DIRECTIONS

      14-Day Course of Treatment

        Repeated 14-Day Courses (if needed)

  • 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

OTHER INFORMATION

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

INACTIVE INGREDIENT SECTION

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


OTHER SAFETY INFORMATION

Tips of Managing Heartburn

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.  

  • 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.