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 ...
Storage and handling
read the directions and warnings before use keep the carton. It contains important information. store at 20-25ºC (68-77ºF)
(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)
PURPOSE
OTC - PURPOSE SECTION
Acid reducer
USE(S)
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
Allergy alert:
· 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 IF YOU HAVE
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
STOP USE AND ASK DOCTOR IF
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
read the directions and warnings before use
keep the carton. It contains important information.
store at 20-25ºC (68-77ºF)
INACTIVE INGREDIENT SECTION
FD&C blue 1, FD&C red 3, FD&C red 40, ferroso ferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di-glycerides, polysorbate 80, potassium hydroxide, shellac, sodium lauryl sulfate, sugar spheres (contains corn starch, sucrose), talc, titanium dioxide, triethyl citrate
QUESTIONS OR COMMENTS?
SPL UNCLASSIFIED SECTION
Call 1-800-883-3540 (Monday - Friday 8 am - 4 pm)
OTHER SAFETY INFORMATION
Tips of 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.
Do not use if seal under bottle cap imprinted with “SEALED FOR YOUR PROTECTION” or blue band around the center of each capsule is broken or missing.
KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.
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