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kirkland signature omeprazole

Costco Wholesale Company

Costco Wholesale Corp. Omeprazole Delayed Release Tablets 20 mg Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Omeprazole 20 mg

Purpose

Acid reducer

kirkland signature omeprazole 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, clopidogrel or cilostazol (blood-thinning medicines)
  • •prescription antifungal or anti-yeast medicines
  • •diazepam (anxiety medicine)
  • •digoxin (heart medicine)
  • •tacrolimus (immune system medicine)
  • •prescription antiretrovirals (medicines 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
  • •you get diarrhea

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)

Directions

  • •for 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; 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 use for more than 14 days unless directed by your doctor
  • •swallow whole. Do not chew or crush tablets
  •  

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

kirkland signature omeprazole Other information

  • •read the directions and warnings before use
  • •keep the carton. It contains important information.
  • •store at 20-25°C (68-77°F) and protect 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

OMEPRAZOLE Delayed Release Tablets 20 mg

Acid Reducer

Treats Frequent Heartburn!

occurring 2 or more days a week

Actual Size

# 14-Day courses of Treatment {Replace “#” with the number of courses of treatment in the package}

kirkland signature omeprazole

Omeprazole TABLET, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63981-915
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OMEPRAZOLE OMEPRAZOLE 20 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
ferric oxide red
FERRIC OXIDE YELLOW
lactose monohydrate
propylene glycol
SODIUM LAURYL SULFATE
sodium stearate
SODIUM STEARYL FUMARATE
talc
titanium dioxide
TRIETHYL CITRATE
MONOETHANOLAMINE
HYPROMELLOSES

Product Characteristics

Color Size Imprint Code Shape
BROWN 17 mm 20 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 14 in 1 BLISTER PACK
2 NDC:63981-915-55 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022032 2008-02-27


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Be sure to consult your doctor before taking any medication!
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