49483-718 Esomeprazole Magnesium Delayed Release Capsules Usp, 20mg

Warnings

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 attention right away.

Uses

• 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

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.

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.

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

Ask a doctor or pharmacist before use if you are

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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

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.

Inactive ingredients black iron oxide, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.

Questions or comments? Call 1-877-290-4008

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Acid reducer

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg

esomeprazole magnesium trihydrate)

Other information

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

Uses

• 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

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.

Warnings

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 attention right away.

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.

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

Ask a doctor or pharmacist before use if you are

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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

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.

Inactive ingredients black iron oxide, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate.

Questions or comments? Call 1-877-290-4008

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Acid reducer

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg

esomeprazole magnesium trihydrate)

Other information

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