Drug Facts

Drug Facts
SPL v30
SPL
SPL Set ID 4513934d-0cf0-40fc-a348-b4e75a33b094
Route
ORAL
Published
Effective Date 2022-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Esomeprazole (20 mg)
Inactive Ingredients
Starch, Corn D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Ferric Oxide Red Gelatin, Unspecified Glyceryl Monostearate Hydroxypropyl Cellulose (1600000 Wamw) Hypromellose, Unspecified Magnesium Stearate Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Polysorbate 80 Sucrose Talc Titanium Dioxide Triethyl Citrate Carminic Acid Fd&c Blue No. 2 Fd&c Red No. 3

Identifiers & Packaging

Pill Appearance
Imprint: NEXIUM;20;mg Shape: capsule Color: purple Color: yellow Size: 14 mm Size: 10 mm Score: 1
Marketing Status
NDA Active Since 2017-03-01 Until 2017-08-31

Description

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

Purpose

Acid reducer


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and Administration

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 Repeated 14-Day Courses (if needed)
    • 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
    • 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.
Description

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

Section 44425-7

Other Information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5
  • Ask a doctor or pharmacist before use if you are
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Section 51727-6

Inactive Ingredients (Nexium 24HR Capsules)

corn starch, D&C red no. 28, FD&C blue no. 1, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

Inactive Ingredients (Nexium 24HR ClearMinis)

carmine, corn starch, FD&C blue no. 2, FD&C blue no. 2 aluminum lake, FD&C red no. 3, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

Section 53413-1

Questions or comments?

call toll-free weekdays 9 AM to 5 PM EST at 1-866-226-1600

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Allergy Alert:
  • Do not use if you are allergic to esomeprazole
  • Esomeprazole may cause severe skin reactions. Symptoms include:
  • skin reddening
  • blisters
  • rash

If an allergic reaction occurs, stop use and seek medical attention right away.

Additional Information

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION”

or yellow band around the center of each capsule is broken or missing.

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.

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

©2022 GSK group of companies or its licensor

Made in France

For most recent product information, visit www.Nexium24HR.com

Nexium is a registered trademark of AstraZeneca AB and is used under license.

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.

Principal Display Panel

NDC 0573-2450-14

See new warning information

Treats Frequent Heartburn

Nexium ®

24HR

esomeprazole magnesium

delayed-release capsules

20 mg/acid reducer

Capsules

May take 1 to 4 days for full effect

14

CAPSULES

One 14-day course of treatment

000078381 Front Carton

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
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

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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 Repeated 14-Day Courses (if needed)
    • 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
    • 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.
Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other Information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5 (50568-5)
  • Ask a doctor or pharmacist before use if you are
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Section 51727-6 (51727-6)

Inactive Ingredients (Nexium 24HR Capsules)

corn starch, D&C red no. 28, FD&C blue no. 1, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

Inactive Ingredients (Nexium 24HR ClearMinis)

carmine, corn starch, FD&C blue no. 2, FD&C blue no. 2 aluminum lake, FD&C red no. 3, FD&C red no. 40, ferric oxide, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, pharmaceutical ink, polysorbate 80, sucrose, talc, titanium dioxide, triethyl citrate

Section 53413-1 (53413-1)

Questions or comments?

call toll-free weekdays 9 AM to 5 PM EST at 1-866-226-1600

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Acid reducer

Allergy Alert: (Allergy alert:)
  • Do not use if you are allergic to esomeprazole
  • Esomeprazole may cause severe skin reactions. Symptoms include:
  • skin reddening
  • blisters
  • rash

If an allergic reaction occurs, stop use and seek medical attention right away.

Additional Information

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION”

or yellow band around the center of each capsule is broken or missing.

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.

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

©2022 GSK group of companies or its licensor

Made in France

For most recent product information, visit www.Nexium24HR.com

Nexium is a registered trademark of AstraZeneca AB and is used under license.

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0573-2450-14

See new warning information

Treats Frequent Heartburn

Nexium ®

24HR

esomeprazole magnesium

delayed-release capsules

20 mg/acid reducer

Capsules

May take 1 to 4 days for full effect

14

CAPSULES

One 14-day course of treatment

000078381 Front Carton

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
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

Advanced Ingredient Data


Raw Label Data

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