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)

Purpose
Acid reducer


Use


Warning
Allergy alert:

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?

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.



acid pump











frequent heartburn


14-Day Course of Treatment


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





Allergy alert:

Do not use

Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if If pregnant or breast-feeding,


Keep out of reach of children.









1-800-719-9260




Dexcel Pharma Technologies Ltd.



Inner Carton


Frequent


Omeprazole



14


Innter Carton Label


Bottle Label


NOT FOR RESALE

Frequent
2 or More Days a Week






14






Dexcel Pharma Technologies Ltd.





Bottle Label







Bulk 7-Count Blister Pack Carton Label














Bulk 7-Count Blister Pack Carton Label

OMEPRAZOLE  DELAYED RELEASE
omeprazole   tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 64239-303
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
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
Color brown (brownish) Score no score
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code 20
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 64239-303-01 14 TABLET In 1 BOTTLE, PLASTIC None
2 64239-303-02 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK
2 7 TABLET In 1 BLISTER PACK This package is contained within the CARTON (64239-303-02)
3 64239-303-03 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK
3 7 TABLET In 1 BLISTER PACK This package is contained within the CARTON (64239-303-03)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022032 03/01/2008

Labeler - Dexcel Pharma Technologies Ltd. (600209951)
Establishment
Name Address ID/FEI Operations
Dexcel Pharma Technologies Ltd. 600209951 manufacture, analysis
Establishment
Name Address ID/FEI Operations
Dexcel Pharma Technologies Ltd. 533597626 manufacture
Revised: 01/2011 Dexcel Pharma Technologies Ltd.