472 - Esomeprazole Magnesium 20mg

472 - Esomeprazole Magnesium 20mg
SPL v2
SPL
SPL Set ID 42fa9084-89db-45ad-8212-4eeb53659a98
Route
ORAL
Published
Effective Date 2025-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Iron Oxides Fd&c Blue No. 1 Fd&c Blue No. 2 Gelatin Glyceryl Monostearate Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Potassium Hydroxide Polysorbate 80 Propylene Glycol Shellac Sodium Lauryl Sulfate Ammonia Sucrose Starch, Corn Talc Titanium Dioxide Triethyl Citrate Dimethicone, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: E4;H Shape: capsule Color: blue Color: white Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2025-05-15

Description

Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

Use(s)
  • 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 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.
Do Not Use
  • 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.
Other Information

read the directions and warnings before use

• keep the carton. It contains important information.

• store at 20-25°C (68-77°F)

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.

Questions/comments

Call 1-888-952-0050 Monday through Friday

9AM – 5PM EST

Active Ingredient(s)

Esomeprazole 20 mg

(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

Inactive Ingredients

Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose,

hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide,

polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia

solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

Principal Display Panel

Esomeprazole Magnesium Label
Esomeprazole Magnesium 14ct
Esomeprazole Magnesium 42ct

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
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 Breastfeeding,

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.

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(s)
  • 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.
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.
Do Not Use (Do not use)
  • 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.
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)

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.

Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday

9AM – 5PM EST

Active Ingredient(s) (Active ingredient(s))

Esomeprazole 20 mg

(*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

Inactive Ingredients (Inactive ingredients)

Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose,

hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide,

polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia

solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

Principal Display Panel

Esomeprazole Magnesium Label
Esomeprazole Magnesium 14ct
Esomeprazole Magnesium 42ct

Ask A Doctor Before Use If (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
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 Breastfeeding, (If pregnant or breastfeeding,)

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.

Ask A Doctor Or Pharmacist Before Use If (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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