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 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 2017-10-16

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: FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

PRODUCT OF INDIA

1-877-846-9949

© 2019 Ahold Delhaize Licensing Sàrl

Quality guaranteed or your money back.

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)

CAREone^®

NDC 72476-500-05

ESOMEPRAZOLE MAGNESIUM

Delayed-Release Capsules USP 20 mg*

Acid Reducer

24 hr

Treats Frequent Heartburn

May take 1 to 4 days for full effect

One 14-day

course of treatment

14 CAPSULES

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

CAREone^®

NDC 72476-500-05

Compare to the active ingredient

in Nexium^® 24 HR

See new warning Information

ESOMEPRAZOLE MAGNESIUM

Delayed-Release Capsules USP 20 mg*

Acid Reducer

24 hr

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Capsules

Actual Size

14 CAPSULES

One 14-day course of treatment

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

CAREone^®

NDC 72476-500-03

Compare to the active ingredient

in Nexium ^® 24 HR

See new warning information

ESOMEPRAZOLE MAGNESIUM

Delayed-Release Capsules USP 20 mg*

Acid Reducer

24 HR

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Capsules

Actual size

42 CAPSULES

(3 bottles of 14 each)

Three 14-day courses 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

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: FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

PRODUCT OF INDIA

1-877-846-9949

© 2019 Ahold Delhaize Licensing Sàrl

Quality guaranteed or your money back.

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))

CAREone^®

NDC 72476-500-05

ESOMEPRAZOLE MAGNESIUM

Delayed-Release Capsules USP 20 mg*

Acid Reducer

24 hr

Treats Frequent Heartburn

May take 1 to 4 days for full effect

One 14-day

course of treatment

14 CAPSULES

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

CAREone^®

NDC 72476-500-05

Compare to the active ingredient

in Nexium^® 24 HR

See new warning Information

ESOMEPRAZOLE MAGNESIUM

Delayed-Release Capsules USP 20 mg*

Acid Reducer

24 hr

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Capsules

Actual Size

14 CAPSULES

One 14-day course of treatment

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

CAREone^®

NDC 72476-500-03

Compare to the active ingredient

in Nexium ^® 24 HR

See new warning information

ESOMEPRAZOLE MAGNESIUM

Delayed-Release Capsules USP 20 mg*

Acid Reducer

24 HR

Treats Frequent Heartburn

May take 1 to 4 days for full effect

Capsules

Actual size

42 CAPSULES

(3 bottles of 14 each)

Three 14-day courses 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", "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: FOODHOLD U.S.A., LLC LANDOVER, MD 20785 PRODUCT OF INDIA 1-877-846-9949 © 2019 Ahold Delhaize Licensing Sàrl Quality guaranteed or your money back. 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)": "CAREone ® NDC 72476-500-05 ESOMEPRAZOLE MAGNESIUM Delayed-Release Capsules USP 20 mg* Acid Reducer 24 hr Treats Frequent Heartburn May take 1 to 4 days for full effect One 14-day course of treatment 14 CAPSULES", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsules Container Carton)": "CAREone ® NDC 72476-500-05 Compare to the active ingredient in Nexium ® 24 HR See new warning Information ESOMEPRAZOLE MAGNESIUM Delayed-Release Capsules USP 20 mg* Acid Reducer 24 hr Treats Frequent Heartburn May take 1 to 4 days for full effect Capsules Actual Size 14 CAPSULES One 14-day course of treatment", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Capsules Container Carton)": "CAREone ® NDC 72476-500-03 Compare to the active ingredient in Nexium ® 24 HR See new warning information ESOMEPRAZOLE MAGNESIUM Delayed-Release Capsules USP 20 mg* Acid Reducer 24 HR Treats Frequent Heartburn May take 1 to 4 days for full effect Capsules Actual size 42 CAPSULES (3 bottles of 14 each) Three 14-day courses of treatment"}