OMEPRAZOLE- omeprazole tablet, delayed release 
VALU MERCHANDISERS COMPANY

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Omeprazole

Drug Facts

Active ingredient (in each tablet)

Omeprazole USP 20 mg

Purpose

Acid reducer

Use

Warnings

Allergy alert

  • do not use if you are allergic to omeprazole.
  • omeprazole may cause severe skin reactions.
    Symptoms may include:
    • skin reddening
    • blisters
    • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use if you have

  • trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • 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

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.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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
  • you get diarrhea
  • you develop a rash or joint pain

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

Other information

Inactive ingredients

anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide.

The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.

Questions or Comments?

Call toll free 1-800-818-4555 weekdays.

PROUDLY DISTRIBUTED BY:
ASSOCIATED WHOLESALE GROCERS, INC.
KANSAS CITY, KANSAS 66106

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton

Best
Choice®

Compare to
Prilosec OTC®*

See new warning information

ACID REDUCER

Omeprazole

DELAYED-RELEASE
TABLETS 20 mg

24
HOUR

14
TABLETS

Treats Frequent
Heartburn

May take 1 to 4 days
for full effect

SWALLOW-DO NOT CHEW

One 14-day course of treatment

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton
OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-997
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MPA.S) (UNII: 36BGF0E889)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
AMMONIA (UNII: 5138Q19F1X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
ColorBROWN (brownish pink) Scoreno score
ShapeOVAL (biconvex) Size12mm
FlavorImprint Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-997-423 in 1 CARTON07/21/2018
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:63941-997-141 in 1 CARTON07/21/2018
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20789107/20/2018
Labeler - VALU MERCHANDISERS COMPANY (868703513)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(63941-997) , MANUFACTURE(63941-997)

Revised: 12/2023
Document Id: 9c033207-ae1c-4212-aeef-3bb5bfef6fca
Set id: 7b2d41b6-3e36-4973-b5f6-adf9b828f40d
Version: 2
Effective Time: 20231213
 
VALU MERCHANDISERS COMPANY