Prilosec OTC
Omeprazole Magnesium · Tablet, Delayed Release · Oral
Active ingredient
Active ingredient (in each tablet) Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Purpose
Purpose Acid reducer
Uses
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
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
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 shoulderpain 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
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
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
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
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children.
Directions
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, crush, or suck 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
Other information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F) and protect from moisture
Inactive ingredients
Inactive ingredients FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, flavor, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, polyethylene glycol 6000, polysorbate 80, polyvinylpyrrolidone, saccharin sodium, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate
Questions?
Questions? 1-800-289-9181
Label text from the FDA structured product label by The Procter & Gamble Manufacturing Company (revised Oct 1, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Omeprazole Magnesium in 4 products
Prilosec OTC NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 84126-300 | Omeprazole Magnesium 20.6 mg/1 Tablet, Delayed Release | The Procter & Gamble Manufacturing Company | ANDA |
| 84126-301 | Omeprazole Magnesium 20.6 mg/1 Tablet, Delayed Release | The Procter & Gamble Manufacturing Company | ANDA |
| 37000-455 | Omeprazole Magnesium 20.6 mg/1 Tablet, Delayed Release | The Procter & Gamble Manufacturing Company | NDA |
| 37000-459 | Omeprazole Magnesium 20 mg/1 Tablet, Delayed Release | The Procter & Gamble Manufacturing Company | NDA |
Frequently asked questions
What is Prilosec OTC used for?
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
Who makes Prilosec OTC?
Prilosec OTC is listed by 1 labeler in the FDA NDC directory, including The Procter & Gamble Manufacturing Company.