QUALITY CHOICE OMEPRAZOLE  - omeprazole tablet, delayed release 
Chain Drug Marketing Association

----------

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

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.

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?

Call 1-800-540-3765

Principal Display Panel

NDC 63868-170-42

QUALITY CHOICE

Treats Frequent Heartburn!

Occurring 2 or more days a week

Omeprazole

Delayed Release Tablets, 20mg

Frequent Heartburn Relief

Acid Reducer

42 Tablets

Three 14-day courses of treatment

omeprazole carton

QUALITY CHOICE OMEPRAZOLE  
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-170
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
ColorbrownScoreno score
ShapeOVAL (capsule-shaped) Size13mm
FlavorImprint Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-170-423 in 1 CARTON
114 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203203/01/2014
Labeler - Chain Drug Marketing Association (011920774)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 5/2014
Document Id: a958dac3-8156-4222-a379-82fb3c229a74
Set id: 0022ca14-9177-4fe9-90f3-1d67592d8d6c
Version: 1
Effective Time: 20140522
 
Chain Drug Marketing Association