ACID REDUCER - omeprazole tablet, delayed release 
Rugby Laboratories

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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 a prescription drug.
Acid reducers may interact with certain prescription drugs.

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 and ethyl acrylate 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 1-800-645-2158

Distributed by:
RUGBY® LABORATORIES
17177N Laurel Park Drive, Suite 233
Livonia, MI 48152

Made in India

Code: TS/DRUGS/22/2009

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

Rugby®            
NDC 0536-1322-88
Omeprazole
Delayed-Release Tablets 20 mg
Acid Reducer
24 Hour
Treats Frequent Heartburn
14 Tablets
One 14-day course of treatment
May take 1 to 4 days for full effect


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



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

Rugby®
NDC 0536-1322-88
Compare to the
active ingredient in
Prilsec OTC®*
Omeprazole
Delayed-Release Tablets
20 mg
Acid Reducer
Actual Size
24 Hour
Treats Frequent Heartburn
14 Tablets
One 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:0536-1322
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:0536-1322-881 in 1 CARTON09/15/2020
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0536-1322-712 in 1 CARTON09/15/2020
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0536-1322-133 in 1 CARTON09/15/2020
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20687709/15/2020
Labeler - Rugby Laboratories (079246066)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(0536-1322) , MANUFACTURE(0536-1322)

Revised: 12/2023
Document Id: cc1710a6-25a0-4478-b1a8-89ac1f85f89e
Set id: 33990795-e994-4307-a570-9e8e8b44c473
Version: 3
Effective Time: 20231202
 
Rugby Laboratories