Omeprazole Tablets

Pronunciation

Dosage Form: tablet, delayed release

Omeprazole Delayed Release Tablets, 20 mg

Omeprazole Delayed Release Tablets, 20 mg Drug Facts


Active ingredient (in each tablet)
Omeprazole delayed-release tablet, 20 mg

Purpose
Acid reducer


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 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

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

  • 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
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

Inner Carton Label


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


Blister Label


Omeprazole DR Tablets
20 mg

Acid reducer
Push tablet through foil.
Dexcel Ltd.
1 Dexcel St.  Or Akiva
30600, Israel

Do not chew or crush tablets

Do not crush tablets in food



Bottle Label


NOT FOR RESALE

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

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:
Dexcel® Ltd.
1 Dexcel St., Or Akiva
30600, Israel

Made in Israel




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.

How Omeperazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn

Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid.  Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days.

What to Expect When Using Omeprazole Delayed Release Tablets 20 mg

Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.  Make sure you take the entire 14 days of dosing to treat your frequent heartburn.

Safety Record

For years, doctors have prescribed omeprazole to treat acid-related conditions in millions of people safely.

Who Should Take Omeprazole Delayed Release Tablets 20 mg

This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week.
  • 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.
How to Take Omeprazole Delayed Release Tablets 20 mg

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.
It is important not to chew or crush these tablets, or crush the tablets in food.  This decreases how well Omeprazole Delayed Release Tablets 20 mg work.

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

Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

Warnings and When to Ask Your Doctor

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
  • 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.  (1-800-222-1222)

Tips for Managing Heartburn
  • 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.
How are Omeprazole Delayed Release Tablets 20 mg Sold

Omeprazole Delayed Release Tablets 20 mg are available in 14 tablet, 28 tablet and 42 tablet sizes.  These sizes contain one, two and three 14-day courses of treatment, respectively.  Do not use for more than 14 days in a row unless directed by your doctor.  For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For Questions or Comments About Omeprazole Delayed Release Tablets 20 mg

Call 1-800-719-9260

Made in Israel

Manufactured by:
DEXCEL® LTD.
Southern Industrial Zone
Or Akiva 30600, Israel


Bulk 7-Count Blister Pack Carton Label


70 Tablets

OMEPRAZOLE DR TABLETS 20 MG OTC
Acid reducer

FOR REPACKAGING ONLY

Manufactured by:  DEXCEL® LTD.
Southern Industrial Zone, Or Akiva 30600, Israel

  • Store at 15° - 25°C (59° - 77°F)
  • Keep product out of high heat and humidity
  • Protect product from moisture
OMEPRAZOLE   DELAYED RELEASE
omeprazole tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64861-303
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Omeprazole (Omeprazole) Omeprazole 20 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax  
Ferric Oxide Red  
Ferric Oxide Yellow  
Hypromellose  
Hypromellose Acetate Succinate 12070923 (3 MM2/S)  
Lactose Monohydrate  
Ethanolamine  
Propylene Glycol  
Sodium Lauryl Sulfate  
Sodium Starch Glycolate Type A Potato  
Sodium Stearate  
Sodium Stearyl Fumarate  
Talc  
Titanium Dioxide  
Triethyl Citrate  
Product Characteristics
Color brown (brownish) Score no score
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code 20
Contains         
Packaging
# Item Code Package Description
1 NDC:64861-303-01 14 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE, PLASTIC
2 NDC:64861-303-02 10 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 7 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK
3 NDC:64861-303-03 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
3 7 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022032 03/01/2008
Labeler - Dexcel Ltd. (600534200)
Establishment
Name Address ID/FEI Operations
Dexcel Ltd. 600534200 analysis, label, manufacture, pack
Revised: 04/2010
 
Dexcel Ltd.



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