members mark omeprazole

Dosage form: tablet, delayed release
Ingredients: OMEPRAZOLE 20mg
Labeler: Sam's West Inc
NDC Code: 68196-915

Sam's West, Inc. Omeprazole Delayed Release Tablets 20 mg 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 or clopidogrel (blood-thinning medicine)
  • 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

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

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?

1-800-809-0469

Consumer Information

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 Omeprazole 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.

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.

  • Children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.
  • 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 of 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

  • warfarin or clopidogrel (blood-thinning medicine)
  • 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

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

Distributed By

Perrigo®

Allegan, MI 49010

Manufactured by:

Dexcel Pharma Technologies Ltd.

10 Hakidma Street,

Yokneam, 20692, Israel

91500 00 J5

Principal Display Panel

3 PACK

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

Omeprazole Delayed Release Tablets 20 mg

Acid Reducer

Actual Size

Treats Frequent Heartburn!

Occurring 2 Or More Days A Week

Omeprazole Delayed Release Tablets Carton Image 1

Omeprazole Delayed Release Tablets Carton Image 2

MEMBERS MARK OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-915
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
SODIUM STEARATE 
SODIUM STEARYL FUMARATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
MONOETHANOLAMINE 
Product Characteristics
ColorBROWNScoreno score
ShapeOVALSize17mm
FlavorImprint Code20
Contains    
Packaging
#Item CodePackage Description
1NDC:68196-915-553 CARTON (CARTON) in 1 CARTON
11 BLISTER PACK (BLISTER PACK) in 1 CARTON
114 TABLET, DELAYED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203202/25/2008
Labeler - Sam's West Inc (051957769)

Revised: 12/2011
 
Sam's West Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)