Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

DESCRIPTION SECTION

Drug Facts

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer

Uses

Warnings

Allergy alert:

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

Do not use if you have

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

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

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

     14-Day Course of Treatment Repeated 14-Day Courses (if needed)

Other Information

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg:

FD&C Blue 2, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion, Mono-and Di-Glycerides, Pharmaceutical Ink, Polysorbate 80, Sugar Spheres, Talc, Triethyl Citrate.

Questions or comments?

Call toll-free weekdays 9 AM to 5 PM EST at 1-516-314-0666

Contact Reliable 1 Laboratories LLC or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Made in India

Additional Information

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.

Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PORTECTION" or Blue band around the center of each capsule is broken or missing.

Tips for Managing Heartburn

Marketed by:

Graviti Pharmaceuticals Inc.,

Wilmington, Delaware-19801,

USA.

Made in India

• 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