drug facts

drug facts
SPL v6
SPL
SPL Set ID b4cdf878-61d3-01bd-48c9-4d6f4fbc71df
Route
oral
Published
Effective Date 2019-06-11
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 2019-03-15

Purpose

Acid reducer

Description

*Esomeprazole 20 mg (Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)


Medication Information

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.

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

Purpose

Acid reducer

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

Description

*Esomeprazole 20 mg (Each delayed-release capsule corresponds to 20.7 mg esomeprazole magnesium, USP)

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.

Carton Label

Carton

Container Label

Container Label:

Questions Or Comments

call 1-800-632-6900

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.

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(1-800-222-1222).

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
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Structured Label Content

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.

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

Purpose

Acid reducer

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

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.

Carton Label (Carton label)

Carton

Container Label

Container Label:

Questions Or Comments (Questions or comments)

call 1-800-632-6900

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.

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(1-800-222-1222).

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 Taking (Ask a doctor or pharmacist before use if you are taking)
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Advanced Ingredient Data


Raw Label Data

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