FDA Label for Esomeprazole Magnesium

Active Ingredient(S)

Esomeprazole 20 mg
(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

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

• 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

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 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 (1-800-222-1222)
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
• 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.

Other Information

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

Tips for 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.

Inactive Ingredients

Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose,
hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide,
polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia
solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

Questions/Comments

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

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