Esomeprazole Magnesium Delayed-release Capsules Usp 20 Mg*

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 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 2025-08-30

Medication Information

Purpose

Acid reducer

Description

Active ingredient (in each capsule) *Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate 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.
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 20-25°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 22.3 mg esomeprazole magnesium trihydrate USP)

Inactive Ingredients

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains 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

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

Made in India

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 Capsule Container Label)

GOOD

NEIGHBOR

PHARMACY^®

NDC 46122-821-61

24 HR

Esomeprazole Magnesium

delayed-release capsules USP 20 mg*

Acid Reducer

Treats Frequent Heartburn Capsules

May take 1 to 4 days for full effect

14 Capsules | One 14-day course of treatment

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

#Compare to Nexium^® 24

HR Active ingredient

GOOD

NEIGHBOR

PHARMACY^®

NDC 46122-821-61

See new warning information 24 HR

Esomeprazole

Magnesium

delayed-release capsules USP 20 mg*

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Capsules

actual

size

14 Capsules | One 14-day Course of treatment

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.
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 20-25°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 22.3 mg esomeprazole magnesium trihydrate USP)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains 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

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

Made in India

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 Capsule Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label))

GOOD

NEIGHBOR

PHARMACY^®

NDC 46122-821-61

24 HR

Esomeprazole Magnesium

delayed-release capsules USP 20 mg*

Acid Reducer

Treats Frequent Heartburn Capsules

May take 1 to 4 days for full effect

14 Capsules | One 14-day course of treatment

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

#Compare to Nexium^® 24

HR Active ingredient

GOOD

NEIGHBOR

PHARMACY^®

NDC 46122-821-61

See new warning information 24 HR

Esomeprazole

Magnesium

delayed-release capsules USP 20 mg*

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Capsules

actual

size

14 Capsules | One 14-day Course of treatment

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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. 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 20-25°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 22.3 mg esomeprazole magnesium trihydrate USP)", "Inactive ingredients": "colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains 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 AmerisourceBergen 1 West First Avenue Conshohocken, PA 19428 Questions or Concerns? www.mygnp.com Made in India", "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 Capsule Container Label)": "GOOD NEIGHBOR PHARMACY ® NDC 46122-821-61 24 HR Esomeprazole Magnesium delayed-release capsules USP 20 mg* Acid Reducer Treats Frequent Heartburn Capsules May take 1 to 4 days for full effect 14 Capsules | One 14-day course of treatment ", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)": "#Compare to Nexium ® 24 HR Active ingredient GOOD NEIGHBOR PHARMACY ® NDC 46122-821-61 See new warning information 24 HR Esomeprazole Magnesium delayed-release capsules USP 20 mg* Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect Capsules actual size 14 Capsules | One 14-day Course of treatment "}

Esomeprazole Magnesium Delayed-release Capsules Usp 20 Mg*

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information