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Omeprazole Delayed Release Tablets, 20 mg


Active Ingredient (In each tablet)


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

Warnings


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.

  • 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

  • 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)

Stop use and ask a doctor if

  • 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

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

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


Tamper-evident:

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 WeekOmeprazoledelayed release tablets 20 mgacid reducer14 TABLETSOne 14-day course of treatment

Comparare to Prilosec* OTC active ingredient only

Pharmacist Recommended14 tablet box front


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.