Active Ingredient (In Each Capsule)
Esomeprazole 20 mg (Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium trihydrate USP)
Esomeprazole Magnesium Capsule
FDA Label NDC 73581-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Esomeprazole Magnesium (NDC 73581-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
- Skin reddening
- blisters
- rash.
Symptoms may include:
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.
- Note: 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.
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.
14-Day Course of Treatment:
Repeated 14-Day Courses (if needed):
Other Information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20-25°C (68-77°F)
- Meets USP dissolution test 2
Inactive Ingredients
colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.
Questions Or Comments?
call 1-866-933-6337
Package Label.Principal Display Panel
20 mg (14 Capsule Container Label)
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