Esomeprazole Magnesium

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Description

Esomeprazole Magnesium from GoodSense is a 14-day course of treatment for frequent heartburn. Delayed-release capsules deliver 20 mg acid reducer that helps to prevent excess acid production in the stomach. Take one capsule every day for 14 days for 24-hour heartburn relief. Note that it may take 1-4 days for full effectiveness. These 14-day courses may be repeated once every four months. Compare to active ingredient in Nexium® 24.

Product Details

With continued use, esomeprazole magnesium treats frequent heartburn
20 mg acid reducer per capsule
To be used as a 14-day course of treatment

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Product Facts

Drug Facts

Active ingredient (in each capsule)

Active ingredient	Purpose
Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)	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

Warning

Allergy alert: Do not use if you are allergic to esomeprazole

Do not use if you have:

■ 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 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)

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. As your doctor before use if you have

These may be signs of a serious condition.

As your 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

Ask a doctor or pharmacist before use if you are taking

■ warfarin, clopidogrel or cilostazol (blood-thinning medicines)

■ prescription antifungal or anti-yeast medicines

■ digoxin (heart medicine)

■ diazepam (anxiety medicine)

■ tacrolimus or mycophenolate mofetil (immune system medicines)

■ prescription antiretrovirals (medicines for HIV infection)

■ methotrexate (arthritis medicine) Stop and ask a doctor if

Stop 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

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)

Inactive Ingredients

FD&C blue no. 1, FD&C red no. 3, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellacc, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate