FDA Label for Esomeprazole Magnesium

Active Ingredient(S)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.250 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 effe

Warnings

• 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

• 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 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 Repeated 14-Day Courses (if needed)

• 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
• 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° to 25°C (68° to 77°F).

Inactive Ingredients

FD&C Blue 2, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion, Mono-and Di-Glycerides, Pharmaceutical Ink, Polysorbate 80, Sugar Spheres, Talc, Triethyl Citrate.

Questions/Comments

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

Principal Display Panel

Esomeprazole 20 mg Label 42ct - 017 esomeprazole magnesium capsule delayed relea 1