Label: ESOMEPRAZOLE MAGNESIUM capsule, delayed release

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

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.

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° to 25°C (68° to 77°F).

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 1-844-474-7464.

Contact Graviti Pharmaceuticals Inc., or www.gravitipharma.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Made in India

See new warning information

• Treats Frequent Heartburn

Esomeprazole magnesium delayed-release capsules 20 mg/acid reducer

May take 1 to 4 days for full effect

14 CAPSULES

One 14-day course of treatment Capsules

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

Principal Display Panel - 20 mg Capsules: Container Label

NDC 16571-880-41

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 Days for Full effect

14 Capsules

One 14-day Course of Treatment

Distributed by: Rising Pharma Holdings, Inc.

Principal Display Panel - 20 mg Capsules: Carton Label

NDC 16571-880-41

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 Days for Full effect

14 Capsules

One 14-day Course of Treatment

Distributed by: Rising Pharma Holdings, Inc.

Principal Display Panel - 20 mg Capsules: Carton Label

NDC 16571-880-42

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

24 HR

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 Days for Full effect

42 Capsules

Three 14-day Courses of Treatment

Distributed by: Rising Pharma Holdings, Inc.