Esomeprazole Magnesium Delayed Release Capsules 

Esomeprazole Magnesium Delayed Release Capsules 
SPL v5
SPL
SPL Set ID 8d6c552c-16d9-4e0e-ba1a-04dce8052f95
Route
ORAL
Published
Effective Date 2024-12-18
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Red No. 3 Fd&c Red No. 40 Ferrosoferric Oxide Gelatin Hydroxypropyl Cellulose Hypromellose 2910 (6 Mpa.s) Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Glyceryl Mono- And Dicaprylocaprate Polysorbate 80 Potassium Hydroxide Shellac Sodium Lauryl Sulfate Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: G666 Shape: capsule Color: white Color: blue Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2023-03-24

Description

*Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

*Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)

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.
Other Information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25ºC (68-77ºF)
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 1-800-883-3540 (Monday - Friday 8 am - 4 pm)

Principal Display Panel

NDC 53041-666-07

See new warning information

Esomeprazole Magnesium

Delayed-Release Capsules USP, 20 mg*

Acid Reducer

 

Treats Frequent Heartburn

24 HR Capsules

May take 1 to 4 days for full effect

14 CAPSULES - One 14-day course of treatment



   

Other Safety Information

Tips of 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.


Do not use if seal under bottle cap imprinted with “SEALED FOR YOUR PROTECTION” or blue band around the center of each capsule is broken or missing.

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.   

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
Inactive Ingredient Section

FD&C blue 1, FD&C red 3, FD&C red 40, ferroso  ferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di-glycerides, polysorbate 80, potassium hydroxide, shellac, sodium lauryl sulfate, sugar spheres (contains corn starch, sucrose), talc, titanium dioxide, triethyl citrate

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.

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

Use(s) (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 (PURPOSE)

Acid reducer

Warnings (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 (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)
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25ºC (68-77ºF)
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 1-800-883-3540 (Monday - Friday 8 am - 4 pm)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 53041-666-07

See new warning information

Esomeprazole Magnesium

Delayed-Release Capsules USP, 20 mg*

Acid Reducer

 

Treats Frequent Heartburn

24 HR Capsules

May take 1 to 4 days for full effect

14 CAPSULES - One 14-day course of treatment



   

Other Safety Information (OTHER SAFETY INFORMATION)

Tips of 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.


Do not use if seal under bottle cap imprinted with “SEALED FOR YOUR PROTECTION” or blue band around the center of each capsule is broken or missing.

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.   

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
Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

FD&C blue 1, FD&C red 3, FD&C red 40, ferroso  ferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di-glycerides, polysorbate 80, potassium hydroxide, shellac, sodium lauryl sulfate, sugar spheres (contains corn starch, sucrose), talc, titanium dioxide, triethyl citrate

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 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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