FDA Label for Esomeprazole
View Indications, Usage & Precautions
Esomeprazole Product Label
The following document was submitted to the FDA by the labeler of this product Reliable 1 Laboratories. 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 20.7 mg esomeprazole magnesium, USP)
Purpose
Acid reducer
Uses
treats frequent heartburn (occurs 2 or more days a week)
not intended for innediate 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
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 sings of a serious condition. See your doctor.
Otc - Ask 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, particulary with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking
warfarin, clopifogrel or cilostazol (blood-thinning medicines)
prescription antifungal or anti-yeast medications
digozin (heart medicine)
diazepam (anxiety medicine)
tacrolimus or mycophenolate mofetil (immune system medicines)
prescription antiretovirals (medicines for HIV infections)
methotrexate (arthritis medicine)
Otc - Stop Use
Stop use and ask a doctor if
your heartburn continues or worsens
you need to take this prodcut 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
If pregnant or breast-feeding, ask a health prefessional before use
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contract a Posion Control Center right away.
Directions
adults 18 years of age and older
this prodcut is to be used once a day (every 24 hours), every day for 14 days
make 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 of more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
you may repeart a 14-day course every 4 months
do not take for more than 14 days or more often than every 4 mounths unless directed by a doctor
children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be cuased by a serious condition.
Other Information
each capsule contains: magnesium, 15 mg
read the directions and warmings before use
keep the carton. It contains important information.
store at 20-25°C (68 to 77°F)
Inactive Ingredients
acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1, ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium odixe, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide
Questions Or Comments?
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Package Label.Principal Display Panel
NDC 69618-056-42
Compare to the active ingredient in Nexium® 24 HR**
Esomeprazole Magnesium
Delayed-Release Capsules, USP
20 mg*
Acid Reducer
42 Capsules
Three 14-day Courses of Treatment
* Please review the disclaimer below.