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Name:Berkley And Jensen Omeprazoleacid Reducer
Manufacturer:Bjwc
Category:Over-the-counter (OTC) Marketed Drugs


BJWC Omeprazole Drug Facts

BERKLEY AND JENSEN OMEPRAZOLE ACID REDUCER - omeprazole tablet, delayed release 
BJWC

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BJWC Omeprazole Drug Facts

Active 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?

1-800-934-1204

Principal Display Panel

Value Pack! {Bonus Packages Only}

#-# Tablet Cartons {Bonus Packages Only}

Omeprazole

Delayed Release Tablets 20 mg

Acid Reducer

Actual Size

Treats Frequent Heartburn!

Occurring 2 Or More Days A Week

# 14-day course{s} of treatment

Omeprazole Carton

Omeprazole Carton


BERKLEY AND JENSEN OMEPRAZOLE  ACID REDUCER
omeprazole tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-915
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
ETHANOLAMINE  
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 20
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68391-915-55 3 CARTON ( CARTON) in 1 CARTON contains a CARTON
1 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON This package is contained within the CARTON (68391-915-55) and contains a BLISTER PACK
1 7 TABLET, DELAYED RELEASE ( TABLET) in 1 BLISTER PACK This package is contained within a CARTON and a CARTON (68391-915-55)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022032 02/28/2008

Labeler - BJWC (159082692)

Revised: 06/2009 BJWC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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