Active ingredient (in each capsule)
Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)
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
Warnings
Allergy alert:
• Do not use if you are allergic to esomeprazole
• Esomeprazole may cause severe skin reactions. Symptoms include:
o skin reddening
o blisters
o rash
If an allergic reaction occurs, stop use and seek medical attention 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.
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
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)
Inactive ingredients
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg
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.
Esomeprazole Magnesium Delayed-Release Capsules 20 mg (Mini Capsules)
Inactive ingredients black iron oxide, corn starch, D&C red 27 aluminum lake, 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, sucrose, talc, titanium dioxide, triethyl citrate
Questions or comments
Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
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.
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India
PRINCIPAL DISPLAY PANEL
NDC: 25000-075-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg
14 count bottle label
NDC: 25000-075-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg
14 count carton label
NDC: 25000-112-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)
14 count bottle label
NDC: 25000-112-76
Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules)
14 count carton label
