FDA Label for Esomeprazole Magnesium
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPSULE)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE IF YOU HAVE:
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Esomeprazole Magnesium Product Label
The following document was submitted to the FDA by the labeler of this product Meijer, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Capsule)
Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)
Purpose
Acid reducer
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 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:
• 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
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).
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• 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• 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
acacia, D&C yellow #10, FD&C blue #1, FD&C red #3, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, menthol, methacrylic acid and ethyl acrylate copolymer dispersion, natural and artificial cool mint flavor, peppermint oil, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, spearmint oil, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
meijer®
COMPARE TO NEXIUM® 24HR ACTIVE INGREDIENT
Esomeprazole Magnesium
Delayed-Release Capsules, 20 mg | Acid Reducer
24 HR
FLAVORED CAPSULES
COOL MINT FLAVOR
Treats Frequent Heartburn
42 CAPSULES
THREE 14-DAY COURSES OF TREATMENT MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT
Releases a cooling sensation in mouth and throat
Actual Size
* Please review the disclaimer below.