OMEPRAZOLE DELAYED RELEASE- omeprazole tablet, delayed release 
Weeks & Leo Co., Inc.

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Omeprazole Delayed Release Tablets, 20 mg

Active Ingredient (In each tablet)


Omeprazole delayed-release tablet, 20 mg

Purpose

Acid reducer

Use



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.

  • 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 or 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)
  • preswcription antretroivirals (medicines for HIV infection)

Stop use and ask a doctor if

  • side effects occur.  You may report side effects to FDA at 1-800-FDA-1088
  • 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


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

Tamper-evident:

do not use if any blister unit is torn, broken, or shows any signs of tampering.

Carton Label - 14 tablets

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

Comparare to Prilosec* OTC active ingredient only

Pharmacist Recommended

14 tablet box front

14 tablet box front

14 tablet box rear

14 tablet box rear

Blister Label


Omeprazole DR Tablets
20 mg

Acid reducer
Push tablet through foil.
Dexcel Ltd.
1 Dexcel St.  Or Akiva
30600, Israel

Do not chew or crush tablets

Do not crush tablets in food


Blister Label

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® LTD.
Southern Industrial Zone
Or Akiva 30600, Israel


OMEPRAZOLE  DELAYED RELEASE
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-257(NDC:64861-303)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorBROWN (brownish) Scoreno score
ShapeOVAL (capsule-shaped) Size13mm
FlavorImprint Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11383-257-612 in 1 CARTON
114 in 1 BLISTER PACK
2NDC:11383-257-161 in 1 CARTON
214 in 1 BLISTER PACK
3NDC:11383-257-433 in 1 CARTON
314 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203207/12/2011
Labeler - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028REPACK(11383-257, 11383-257)

Revised: 10/2012
Document Id: 5b04f51e-2b48-492b-84b1-22e988d46720
Set id: bb7e658c-dab5-43b3-b5c2-578948164e63
Version: 3
Effective Time: 20121010
 
Weeks & Leo Co., Inc.