Walmart Esomeprazole Magnesium Delayed-release Capsules Usp, 20 Mg

Walmart Esomeprazole Magnesium Delayed-release Capsules Usp, 20 Mg
SPL v2
SPL
SPL Set ID 3863bc2c-3120-ad92-e063-6394a90abb20
Route
ORAL
Published
Effective Date 2025-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Fd&c Red No. 3 Shellac Dimethicone Sucrose Talc Fd&c Blue No. 1 Glyceryl Monostearate Ferrosoferric Oxide Starch, Corn Triethyl Citrate Sodium Lauryl Sulfate Hypromellose, Unspecified Ferric Oxide Yellow Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Hydroxypropyl Cellulose, Unspecified Potassium Hydroxide Gelatin, Unspecified Titanium Dioxide Polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: 75 Shape: capsule Color: purple Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2025-09-20

Description

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Purpose

Acid Reducer


Medication Information

Purpose

Acid Reducer

Description

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

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 51945-4

Warnings

Allergy alert

• Do not use if you are allergic to esomeprazole

• Esomeprazole may cause severe skin reactions. Symptoms include:

o skin reddening

o blisters

o rash

If an allergic reaction occurs, stop use and seek medical attention 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

o swallow 1 capsule with a glass of water before eating in the morning

o take every day for 14 days

o do not take more than 1 capsule a day

o swallow whole. Do not crush or chew capsules.

o do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

o you may repeat a 14-day course every 4 months

o 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.



Drug Facts

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Other Information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F)
Inactive Ingredients

black iron oxide, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

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.

Questions Or Comments?

Call 1-888-287-1915

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.

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 (1-800-222-1222) right away.

Active Ingredient (in Each Capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

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.

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 51945-4 (51945-4)

Purpose

Acid Reducer

Warnings

Allergy alert

• Do not use if you are allergic to esomeprazole

• Esomeprazole may cause severe skin reactions. Symptoms include:

o skin reddening

o blisters

o rash

If an allergic reaction occurs, stop use and seek medical attention 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

o swallow 1 capsule with a glass of water before eating in the morning

o take every day for 14 days

o do not take more than 1 capsule a day

o swallow whole. Do not crush or chew capsules.

o do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

o you may repeat a 14-day course every 4 months

o 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.



Drug Facts

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

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)
Inactive Ingredients (Inactive ingredients)

black iron oxide, eudragit, FD&C blue 1, FD&C red 3, ferric oxide yellow, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 80, potassium hydroxide, shellac, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

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 lightheadedness

• frequent chest pain

These may be signs of a serious condition. See your doctor.

Questions Or Comments? (Questions or comments?)

Call 1-888-287-1915

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.

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.

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 (1-800-222-1222) right away.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

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
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

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