Omeprazole
Dexcel Pharma Technologies Ltd.
Omeprazole Delayed Release Tablets, 20 mg
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Drug Facts
Active ingredient (in each tablet)
Purpose
Purpose
Acid reducer
Uses
Use
- 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 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.
Ask a doctor before use if you have
- 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
Ask a doctor or pharmacist before use if you are taking
- 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)
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
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.
(1-800-2221222)
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
- 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
Other information
- 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
Inactive ingredients
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
Questions or comments?
Patient Package Insert
Omeprazole Delayed Release Tablets 20 mg
Acid Reducer
Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg. Save this to read, as you need.
acid pump
frequent heartburn
- 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.
14-Day Course of Treatment
- 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.
When to Take Omeprazole Delayed Release Tablets 20 mg Again
You may repeat a 14-day course of therapy every 4 months.
When to Talk to Your Doctor
Allergy alert:
Do not use
Ask a doctor before use if you have
- 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
Keep out of reach of children.
- 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.
1-800-719-9260
Dexcel Pharma Technologies Ltd.
Inner Carton
Frequent
Omeprazole
14
Bottle Label
NOT FOR RESALE
Frequent
2 or More Days a Week
14
Dexcel Pharma Technologies Ltd.
Bulk 7-Count Blister Pack Carton Label
- Store at 15° - 25°C (59° - 77°F)
- Keep product out of high heat and humidity
- Protect product from moisture
84 Tablets
OMEPRAZOLE DR TABLETS 20MG OTC
Acid Reducer
FOR REPACKAGING ONLY
Manufactured by:
Dexcel Pharma Technologies Ltd.
10 Hakidma Street, Hi-Tech Park,
Yokneam, 20692, Israel
- Store at 15° - 25°C (59° - 77°F)
- Keep product out of high heat and humidity
- Protect product from moisture
OmeprazoleOmeprazole TABLET, DELAYED RELEASE
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