Esomeprazole Magnesium Delayed-release Capsules Usp 20 Mg*

Esomeprazole Magnesium Delayed-release Capsules Usp 20 Mg*
SPL v6
SPL
SPL Set ID d226cda0-5cdb-4e2d-a865-530a8f09a095
Route
ORAL
Published
Effective Date 2024-04-27
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Blue No. 1 Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Carbonate Magnesium Oxide Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Glyceryl Monostearate Polysorbate 80 Propylene Glycol Shellac Sodium Lauryl Sulfate Ammonia Dextrose, Unspecified Form Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: I81 Shape: capsule Color: white Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2019-07-09
Description

Active ingredient   (in each capsule)   *Esomeprazole 20 mg (Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

Active ingredient   (in each capsule)   *Esomeprazole 20 mg (Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate 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
Warnings

Allergy alert: Do not use if you are allergic to esomeprazole

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 20-25°C (68-77°F)
  • Meets USP dissolution test 2
Drug Facts

Active ingredient   (in each capsule)  



*Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Inactive Ingredients

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.



Questions or comments?



call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)



Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, Rl 02895

©2019 CVS/pharmacy

CVS.com® 1-800-SHOP CVS



Made in India



Code: TS/DRUGS/22/2009

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.

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 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
Ask A Doctor Or Pharmacist Before Use If You Are
  •  taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Package Label Principal Display Panel 20 Mg (14 Capsules Container Label)

CVSHealthTM

Treats Frequent Heartburn

May take 1 to 4 days for full effect     24 HOUR



Esomeprazole Magnesium

DELAYED-RELEASE CAPSULES USP 20 mg*

Acid reducer

 14 CAPSULES

 One 14-day course of treatment



Package Label Principal Display Panel 20 Mg (14 Capsules Container Carton)

CVSHealthTM

Compare to the active

 ingredient in Nexium® 24 HR**

Treats Frequent Heartburn

 May take 1 to 4 days for full effect         24 HOUR

Esomeprazole Magnesium

 DELAYED-RELEASE

 CAPSULES USP 20 mg*

Acid reducer

 See new warning information



 14 CAPSULES

 One 14-day Course

 of treatment                 Actual Size



Package Label Principal Display Panel 20 Mg (28 Capsules Container Carton)

CVSHealthTM

Compare to the active

ingredient in Nexium® 24 HR**

Treats Frequent Heartburn

May take 1 to 4 days for full effect       24 HOUR

Esomeprazole Magnesium

 DELAYED-RELEASE

CAPSULES USP 20 mg*

Acid Reducer

 See new warning information

28 CAPSULES

 (2 bottles of 14 each)

 Two 14-day courses of treatment           Actual Size







Package Label Principal Display Panel 20 Mg (42 Capsules Container Carton)

CVSHealthTM

Compare to the active

ingredient in Nexium® 24 HR**

Treats Frequent Heartburn

 May take 1 to 4 days for full effect     24 HOUR

Esomeprazole Magnesium

 DELAYED-RELEASE

 CAPSULES USP 20 mg*

Acid reducer

 See new warning information

42 CAPSULES

 (3 bottles of 14 each)

 Three 14-day courses of treatment         Actual Size







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
Purpose

Acid reducer

Warnings

Allergy alert: Do not use if you are allergic to esomeprazole

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 20-25°C (68-77°F)
  • Meets USP dissolution test 2
Drug Facts

Active ingredient   (in each capsule)  



*Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.



Questions or comments?



call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)



Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, Rl 02895

©2019 CVS/pharmacy

CVS.com® 1-800-SHOP CVS



Made in India



Code: TS/DRUGS/22/2009

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.

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, 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
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.
Package Label Principal Display Panel 20 Mg (14 Capsules Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Label))

CVSHealthTM

Treats Frequent Heartburn

May take 1 to 4 days for full effect     24 HOUR



Esomeprazole Magnesium

DELAYED-RELEASE CAPSULES USP 20 mg*

Acid reducer

 14 CAPSULES

 One 14-day course of treatment



Package Label Principal Display Panel 20 Mg (14 Capsules Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Carton))

CVSHealthTM

Compare to the active

 ingredient in Nexium® 24 HR**

Treats Frequent Heartburn

 May take 1 to 4 days for full effect         24 HOUR

Esomeprazole Magnesium

 DELAYED-RELEASE

 CAPSULES USP 20 mg*

Acid reducer

 See new warning information



 14 CAPSULES

 One 14-day Course

 of treatment                 Actual Size



Package Label Principal Display Panel 20 Mg (28 Capsules Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (28 Capsules Container Carton))

CVSHealthTM

Compare to the active

ingredient in Nexium® 24 HR**

Treats Frequent Heartburn

May take 1 to 4 days for full effect       24 HOUR

Esomeprazole Magnesium

 DELAYED-RELEASE

CAPSULES USP 20 mg*

Acid Reducer

 See new warning information

28 CAPSULES

 (2 bottles of 14 each)

 Two 14-day courses of treatment           Actual Size







Package Label Principal Display Panel 20 Mg (42 Capsules Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Capsules Container Carton))

CVSHealthTM

Compare to the active

ingredient in Nexium® 24 HR**

Treats Frequent Heartburn

 May take 1 to 4 days for full effect     24 HOUR

Esomeprazole Magnesium

 DELAYED-RELEASE

 CAPSULES USP 20 mg*

Acid reducer

 See new warning information

42 CAPSULES

 (3 bottles of 14 each)

 Three 14-day courses of treatment         Actual Size







Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:03.598077 · Updated: 2026-03-14T23:02:54.359020