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FDA LABEL GENERIC: Esomeprazole MFR: Haleon US Holdings LLC

Nexium 20 Mg Delayed Release Oral Tablet

Active ingredient (in each tablet)

Esomeprazole 20 mg

(Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer

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

WARNINGS

Warnings

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.

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.

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.

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.

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 swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day swallow whole. Do not crush or chew tablets. 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)

Inactive ingredients

corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate

Questions or comments?

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

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.

PRINCIPAL DISPLAY PANEL

NDC 0573-2451-14

See new warning information

Treats Frequent Heartburn

Nexium®
24HR

esomeprazole magnesium

delayed-release tablets
20 mg/acid reducer

Tablets

May take 1 to 4 days for full effect

14
TABLETS

One 14-day course of treatment

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