EQUATE OMEPRAZOLE- omeprazole tablet, delayed release 
Praxis, LLC

----------

Wal-Mart Omeprazole Delayed Release Tablets 20 mg Drug Facts

Active ingredient (in each tablet)

Omeprazole 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
  • 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

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

benzyl alcohol, carmine, carnauba wax, FD&C blue #2/indigo carmine aluminum lake, flavor, hypromellose, hypromellose acetate succinate, lactose monohydrate, menthol, modified starch, monoethanolamine, polyethylene glycol 3350, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, sucralose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-888-287-1915

Package/Label Principal Display Panel

3 PACK

THREE 14-DAY COURSES OF TREATMENT

equate

Compare to Prilosec OTC ®

Omeprazole Delayed Release Tablets 20 mg

Acid Reducer

Treats Frequent Heartburn!

24 HR

Actual Size

SWALLOW – DO NOT CHEW

WILDBERRY MINT COATED TABLET

20 mg

42 TABLETS

Three 14-day courses of treatment

May take 1 to 4 days for full effect

3 Bottles Inside

See Current Drug Facts

omeprazole image 1
omeprazole image 2
EQUATE OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59368-327
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize12mm
FlavorBERRYImprint Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59368-327-011 in 1 CARTON09/02/2015
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59368-327-023 in 1 CARTON09/02/2015
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203209/02/2015
Labeler - Praxis, LLC (016329513)
Establishment
NameAddressID/FEIBusiness Operations
Praxis, LLC016329513manufacture(59368-327) , label(59368-327) , pack(59368-327)

Revised: 1/2023
Document Id: 311988ee-f818-bf7b-e063-6294a90a5f88
Set id: 31198650-1549-b708-e063-6394a90ad60c
Version: 1
Effective Time: 20230101
 
Praxis, LLC