ACID REDUCER - omeprazole tablet, delayed release 
DISCOUNT DRUG MART

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Tips for Managing Heartburn

Drug Facts

Active ingredient (in each tablet)

Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)

Purpose

Acid reducer

Use

Warnings

Allergy alert:

Do not use if you are allergic to omeprazole

Do not use if you have:

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 (1-800-222-1222)  right away.

Directions

14-Day Course of Treatment

Repeated 14-Day Courses (if needed)

Other information

Inactive ingredients

crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide,  triethyl citrate and yellow iron oxide.

Questions?

Call 1-855-274-4122

Distributed by:
Discount Drug Mart
211 Commerce Drive, Medina, OH 44256
www.discount-drugmart.com
Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)

NDC 53943-016-05
Discount
drug
mart
FOOD FAIR
Omeprazole
Delayed-Release Tablets 20 mg
Acid Reducer
24 HR                                                                          14 TABLETS
Treats Frequent Heartburn!           One 14-day course of treatment                                            
                                                       May take 1 to 4 days full effect
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)
          

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label

NDC 53943-016-62
Compare to Prilosec OTC®
Active Ingredient*
Discount
drug
mart
FOOD FAIR
Omeprazole
Delayed-Release Tablets 20 mg
Acid Reducer
24 HR                                                                                                        42 TABLETS
Treats Frequent Heartburn!                                Three 14-day course of treatment                              
                                                                            May take 1 to 4 days for full effect
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label
 

ACID REDUCER 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE (45000 WAMW) (UNII: 8VAB711C5E)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
Product Characteristics
ColorPINKScoreno score
ShapeRECTANGLE (Oblong) Size14mm
FlavorImprint Code Z;69
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-016-051 in 1 CARTON06/06/2018
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:53943-016-623 in 1 CARTON06/06/2018
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20687706/06/2018
Labeler - DISCOUNT DRUG MART (047741335)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(53943-016) , MANUFACTURE(53943-016)

Revised: 11/2022
Document Id: e937688e-de3f-48c6-96c1-2ecd0e391313
Set id: ff2c8446-9d8b-4300-b157-884b48e98bb7
Version: 5
Effective Time: 20221104
 
DISCOUNT DRUG MART