Esomeprazole Magnesium Capsule, Delayed Release
FDA Label NDC 53041-666

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guardian Drug Company for the product Esomeprazole Magnesium (NDC 53041-666). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(in each capsule), purpose, use(s), warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(in Each Capsule)

→ Purpose

→ Use(s)

→ Warnings

→ Do Not Use If You Have

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Stop Use And Ask Doctor If

→ If Pregnant Or Breast-feeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredient Section

→ Questions Or Comments?

→ Other Safety Information

→ Principal Display Panel

Active Ingredient(In Each Capsule)

*Esomeprazole 20 mg

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

Purpose

Acid reducer

Use(S)

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.

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 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.

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)

Inactive Ingredient Section

FD&C blue 1, FD&C red 3, FD&C red 40, ferroso ferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di-glycerides, polysorbate 80, potassium hydroxide, shellac, sodium lauryl sulfate, sugar spheres (contains corn starch, sucrose), talc, titanium dioxide, triethyl citrate

Questions Or Comments?

Call 1-800-883-3540 (Monday - Friday 8 am - 4 pm)

Other Safety Information

Tips of 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.

Do not use if seal under bottle cap imprinted with “SEALED FOR YOUR PROTECTION” or blue band around the center of each capsule is broken or missing.

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.