Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID e3747f1e-01e7-f3cf-499e-c7c3f6d06a30
Route
ORAL
Published
Effective Date 2020-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Acetyltributyl Citrate Dibutyl Sebacate Ferrosoferric Oxide Gelatin Glyceryl Monostearate Hypromelloses Magnesium Oxide Magnesium Stearate Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Poloxamer 188 Polysorbate 80 Povidone K30 Talc Titanium Dioxide Propylene Glycol Potassium Hydroxide Shellac Sucrose Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
ANDA Active Since 2019-03-24

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

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