Omeprazole Delayed Release Tablets, 20 mg

OMEPRAZOLE DELAYED RELEASE - omeprazole tablet, delayed release 
Dexcel Pharma Technologies Ltd.

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Omeprazole Delayed Release Tablets, 20 mg

Drug Facts


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

Purpose
Acid reducer


Use


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

Ask a doctor or pharmacist before use if you are taking

Stop use and ask a doctor if

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
14-Day Course of Treatment Repeated 14-Day Courses (if needed)


Other information

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

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.
How to Take Omeprazole Delayed Release Tablets 20 mg

14-Day Course of Treatment
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
Ask a doctor or pharmacist before use if you are taking
Stop use and ask a doctor if 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
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 Pharma Technologies Ltd.
10 Hakidma Street, Hi-Tech Park,
Yokneam, 20692, Israel

Inner Carton


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

Innter Carton Label


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

Safety Feature - Do not use if printed
seal under cap is broken or missing.

Manufactured by:
Dexcel Pharma Technologies Ltd.
10 Hakidma Street, Hi-Tech Park,
Yokneam, 20692, Israel

Made in Israel

Bottle Label







Bulk 7-Count Blister Pack Carton Label


70 Tablets

OMEPRAZOLE DR TABLETS 20 MG OTC
Acid reducer

FOR REPACKAGING ONLY

Manufactured by:
Dexcel Pharma Technologies Ltd.
10 Hakidma Street, Hi-Tech Park,
Yokneam, 20692, Israel

Bulk 7-Count Blister Pack Carton Label

OMEPRAZOLE  DELAYED RELEASE
omeprazole   tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)64239-303
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 
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
Colorbrown (brownish) Score no score
ShapeOVAL (capsule-shaped) Size13mm
FlavorImprint Code 20
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
164239-303-0114 TABLET In 1 BOTTLE, PLASTICNone
264239-303-0210 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
27 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (64239-303-02)
364239-303-032 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
37 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (64239-303-03)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203203/01/2008

Labeler - Dexcel Pharma Technologies Ltd. (600209951)
Establishment
NameAddressID/FEIOperations
Dexcel Pharma Technologies Ltd.600209951manufacture, analysis
Establishment
NameAddressID/FEIOperations
Dexcel Pharma Technologies Ltd.533597626manufacture
Revised: 01/2011Dexcel Pharma Technologies Ltd.