Esomeprazole Capsule, Delayed Release
FDA Label NDC 57896-740

*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)

Acid reducer

• treats frequent heartburn (occurs 2 or moredays 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:

skin reddening

blisters

rash

• If an allergic reaction occurs, stop use and seek medical help right away.

Do not use if you have:

• 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

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 (1-800-222-1222).

• 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
• Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]
• keep the carton. It contains important information.

FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.

Call toll-free 1-800-540-3765 weekdays.

TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing.

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.

Distributed by:
GERI-CARE PHARMACEUTICALS CORP.
1295 Towbin Avenue
Lakewood, NJ 08701
REV 0326