Otc - Active Ingredient
Omeprazole delayed-release tablet, 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)
The following Structured Product Label (SPL) was submitted to the FDA by Cabinet Health P.b.c. for the product Goodmeds 24hr Acid Reducer Omeprazole 20mg (NDC 82725-4052). 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.
Omeprazole delayed-release tablet, 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)
Acid reducer
Use
• 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 omeprazole.
• Omeprazole 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
• for adults 18 years of age and older
• this product is to be used once a day (every 24 hours), every day for
14 days
• it may take 1 to 4 days for full effect; some people get complete relief
of symptoms within 24 hours
14-Day Course of Treatment
• swallow 1 tablet with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 tablet a day
• do not use for more than 14 days unless directed by your doctor
• swallow whole. Do not chew or crush tablets.
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.
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) and protect from moisture
Inactive ingredients
corn starch, crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, sodium hydroxide, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate.
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