Drug Facts
e3747f1e-01e7-f3cf-499e-c7c3f6d06a30
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
*Esomeprazole 20 mg (Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)
Purpose
Acid reducer
Medication Information
Purpose
Acid reducer
Description
*Esomeprazole 20 mg (Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)
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
Section 42229-5
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.
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
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
- each capsule contains: magnesium, 15 mg
- read directions and warnings before use
- keep the carton. It contains important information
- store at 20 to 25°C (68 to 77°F)
Inactive Ingredients
acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1, ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide
Questions Or Comments
call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
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 lightheadness
- frequent chest pain.
These may be signs of a serious condition. See your doctor.
Principal Display Panel
Container Label:
Stop Use and Ask 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.
Principal Display Panel Carton
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
Active Ingredient(s) in Each Capsule
*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)
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
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
Section 42229-5 (42229-5)
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.
Purpose
Acid reducer
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
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 (Other information)
- each capsule contains: magnesium, 15 mg
- read directions and warnings before use
- keep the carton. It contains important information
- store at 20 to 25°C (68 to 77°F)
Inactive Ingredients (Inactive ingredients)
acetyl tributyl citrate, dibutyl sebacate, FD&C Blue #1, ferroso ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, poloxamer, polysorbate 80, povidone, potassium hydroxide, propylene glycol, shellac, sugar, talc, titanium dioxide
Questions Or Comments (Questions or comments)
call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
Do Not Use If You Have: (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 lightheadness
- frequent chest pain.
These may be signs of a serious condition. See your doctor.
Principal Display Panel
Container Label:
Stop Use and Ask Doctor If (Stop use and ask 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. (Keep out of reach of children.)
In case of overdose, get medical help or contact a Poison Control Center right away.
Principal Display Panel Carton (Principal Display Panel- Carton)
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
Active Ingredient(s) in Each Capsule (Active ingredient(s) in each capsule)
*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)
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
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:54.912188 · Updated: 2026-03-14T23:13:20.000214