Otc - Active Ingredient
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 Cabinet Health P.b.c. for the product Goodmeds Acid Reducer 24hr Esomeprazole Magnesium Delayed-release 20mg (NDC 82725-4053). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, 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
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.
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
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
read the directions and warnings before use
keep the carton. It contains important information.
store at 20° to 25°C (68° to 77°F)
Inactive ingredients
ammonia, black iron oxide, corn starch, dimethicone, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triethyl citrate.
Questions or comments?
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1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM
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