GOOD SENSE OMEPRAZOLE
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omeprazole tablet, delayed release
L Perrigo Company
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Perrigo Omeprazole Delayed Release Tablets 20 mg Drug FactsActive ingredient (in each tablet)
Omeprazole delayed-release tablet, 20 mg
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 omeprazole
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 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
Ask a doctor or pharmacist before use if you are taking
- 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.
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
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
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
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?
1-800-719-9260
Principal Display Panel
Treats Frequent Heartburn!
Occurring 2 Or More Days A Week
Omeprazole
Delayed Release Tablets 20 mg
Acid Reducer
# 14-day course{s} of treatment
Omeprazole Delayed Release Tablets 20 mg Carton
| GOOD SENSE OMEPRAZOLE
omeprazole tablet, delayed release |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA022032 | 02/28/2008 | |
| Labeler - L Perrigo Company (006013346) |