Active Ingredient(S)
Esomeprazole 20 mg
(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Esomeprazole Magnesium (NDC 69168-472). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Esomeprazole 20 mg
(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).
Acid reducer
Allergy alert: Do not use if you are allergic to esomeprazole
you have
you are
ask a health professional before
use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222)
right away.
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
read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20-25°C (68-77°F)
Tips for 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.
Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose,
hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide,
polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia
solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.
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