Drug Facts

Active ingredient   (in each capsule) 

*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

Purpose

Acid reducer

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. (1-800-222-1222)

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)
• Meets USP dissolution test 2

Inactive ingredients

colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide.

Questions or comments?

call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed By Amerisource Bergn
1300 Morris Drive, Chesterbrook, PA 19087
Questions or Concerns?        www.mygnp.com

Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label)

Rx
GOOD                         NDC 46122-538-74                        
NEIGHBOR                                      
PHARMACY®                                      
                                                        24 HR
Esomeprazole Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn         Capsules
May take 1 to 4 days for full effect    
14 Capsules  |one 14-day course  of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)

Rx
GOOD                                                Compare to Nexium® 24 HR
NEIGHBOR                                       active ingredient**
PHARMACY®                                  NDC 46122-538-74
See new warning information                24 HR
Esomeprazole
Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn
May take 1 to 4 days for full effect           actual
14                    Capsules                         size
Capsules |     one 14-day course
                        of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (28 Capsule Container Carton)

Rx
GOOD
NEIGHBOR                                  Compare to Nexium® 24 HR  active ingredient**
PHARMACY®                               NDC 46122-538-03
See new warning information              24 HR
Esomeprazole Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn
May take 1 to 4 days for full effect     Capsules      actual
                                                                                size
28 Capsules | two 14-day courses
(2 bottles of 14 each) | of treatment

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Capsule Container Carton)

Rx
GOOD
NEIGHBOR             Compare to Nexium® 24 HR  active ingredient**
PHARMACY®         NDC 46122-538-04
See new warning information              24 HR
Esomeprazole Magnesium
delayed release capsules USP 20 mg*
Acid Reducer
Treats Frequents Heartburn
May take 1 to 4 days for full effect     Capsules      actual
                                                                                  size
42 Capsules                | three 14-day courses of treatment
(3 bottles of 14 each)