Prilosec Otc®
35a79458-79f6-44d6-b74c-b4f4aaf0dde0
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Acid reducer
Medication Information
Purpose
Acid reducer
Description
Drug Facts
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
Section 34088-5
In case of overdose, get medical help or contact a Poison Control Center right away.
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children.
Section 50570-1
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.
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.
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.
- 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.
Questions?
1-800-289-9181
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
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
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.
Active Ingredient (in Each Tablet)
Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)
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
Principal Display Panel 14 Tablet Carton
See current Drug Facts NDC 37000-459-02
Treats FREQUENT Heartburn! 24 HR
Prilosec OTC ®
omeprazole delayed-release tablets
20 mg / acid reducer
SWALLOW - DO NOT CHEW
14 TABLETS
One 14-day course of treatment
May take 1 to 4 days for full effect
WILDBERRY Coated Tablet
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug.
Acid reducers may interact with certain prescription drugs.
Structured Label Content
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
Section 34088-5 (34088-5)
In case of overdose, get medical help or contact a Poison Control Center right away.
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50570-1 (50570-1)
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.
Purpose
Acid reducer
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.
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.
- 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.
Questions?
1-800-289-9181
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
Stop Use and Ask A Doctor If: (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, (If pregnant or breast-feeding,)
ask a health professional before use.
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))
Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Ask A Doctor Before Use If You Have: (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
Principal Display Panel 14 Tablet Carton (PRINCIPAL DISPLAY PANEL - 14 Tablet Carton)
See current Drug Facts NDC 37000-459-02
Treats FREQUENT Heartburn! 24 HR
Prilosec OTC ®
omeprazole delayed-release tablets
20 mg / acid reducer
SWALLOW - DO NOT CHEW
14 TABLETS
One 14-day course of treatment
May take 1 to 4 days for full effect
WILDBERRY Coated Tablet
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking a prescription drug.
Acid reducers may interact with certain prescription drugs.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:08.566699 · Updated: 2026-03-14T23:10:21.394156