Omeprazole

Weeks & Leo Co., Inc.

Omeprazole Delayed Release Tablets, 20 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• Carton Label - 14 tablets
• Blister Label
• Patient Package Insert

FULL PRESCRIBING INFORMATION

Acid reducer

• 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

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.  These may be signs of a serious condition.  See your doctor.

had heartburn over 3 months.  This may be a sign of a more serious condition.

• had heartburn over 3 months.  This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating or dizziness
• chest pain or shoulder pain with shortness or breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

if you are taking

• warfarin or clopidogrel (blood-thinning medicine)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)
• tacrolimus (immune system medicine)
• preswcription antretroivirals (medicines for HIV infection)

• side effects occur.  You may report side effects to FDA at 1-800-FDA-1088
• 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

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

• adults 18 years of age and older
• this product is to be used once a day (every 24 hours), every day for 14 days
• it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

• swallow 1 tablet with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 tablet a day
• do not chew or crush the tablets
• do not crush tablets in food
• do not use for more than 14 days unless directed by your doctor

• 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.  Heartburn in children may sometimes be caused by a serious condition.

• read the directions, warnings, and package insert before use
• keep the carton and package insert.  They contain important information.
• store at 20-25°C (68-77°F)
• keep product out of high heat and humidity
• protect product from moisture

carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate

do not use if any blister unit is torn, broken, or shows any signs of tampering.

Carton Label - 14 tablets

Treats Frequent Heartburn!
Occurring 2 or More Days a Week

Omeprazole
delayed release tablets 20 mg
acid reducer

14 TABLETS
One 14-day course of treatment

Comparare to Prilosec* OTC active ingredient only

Pharmacist Recommended

Blister Label

Patient Package Insert

• Omeprazole Delayed Release Tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief or heartburn.

• Swallow 1 tablet with a glass of water before eating in the morning.
• Take every day for 14 days.
• Do not take more than 1 tablet a day
• Do not chew or crush the tablets.
• Do not crush tablets in food.
• Do not use for more than 14 days unless directed by your doctor.

• had heartburn over 3 months.  This may be a sign of a more serious condition
• 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
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

• clopidogrel bisulfate (anti-blood clotting medicine)
• warfarin (blood-thinning medicine)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)
• tacrolimus (immune system medicine)
• atazanavir (medicine for HIV infection)

• 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

• Do not lie flat or bend over soon after eating.
• Do not eat late at night or just before bedtime.
• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables.
• Eat slowly and do not eat big meals.
• If you are overweight, lose weight.
• If you smoke, quit smoking.
• Raise the head of your bed.
• Wear loose-fitting clothing around your stomach.