49483-718 Esomeprazole magnesium delayed release capsules USP, 20mg
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each capsule)
Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 22.3 mg
esomeprazole magnesium trihydrate)
OTC - PURPOSE SECTION
Purpose
Acid reducer
INDICATIONS & USAGE SECTION
Uses
- 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
WARNINGS SECTION
Warnings
Allergy alert
-skin reddening -blisters -rash
If an allergic reaction occurs, stop use and seek medical attention right away.
- Do not use if you are allergic to esomeprazole
- Esomeprazole may cause severe skin reactions. Symptoms include:
OTC - DO NOT USE SECTION
Do not use if you have
These may be signs of a serious condition. See your doctor.
- 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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
- 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
OTHER SAFETY INFORMATION
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 INGREDIENT SECTION
Inactive ingredientsblack 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.
OTC - QUESTIONS SECTION
Questions or comments?Call 1-877-290-4008