OMEPRAZOLE- omeprazole tablet, delayed release 
CHAIN DRUG MARKETING ASSOCIATION, INC.

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Omeprazole Delayed-Release Tablets, 20 mg/acid reducer

Active ingredient (in each tablet)

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


Purpose

Acid reducer

Use


• treats frequent heartburn (occurs 2 or moredays a week)
• not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect


Warnings


Allergy alert:

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.

Directions



• for adults 18 years of age and older
• this product is to be used once a day (every 24 hours), every day for 14 days
• it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours
14-Day Course of Treatment
• swallow 1 tablet with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 tablet a day
• do not use for more than 14 days unless directed by your doctor
swallow whole. Do not chew or crush tablets.
Repeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months
do not take for more than 14 days or more often than every 4 months unless directed by a doctor
• children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.


Other information


• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20° to 25° C (68° to 77° F) and protect from moisture


Inactive ingredients


colloidal silicon dioxide, crospovidone, glyceryl monostearate, hypromellose, hydroxypropyl cellulose, iron oxide red, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium hydroxide, sodium lauryl sulphate, starlac (contains lactose monohydrate and corn starch), sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

Questions?

1-888-375-3784

PRINCIPAL DISPLAY PANEL

 

NDC 83324-011-42

See Current Drug Facts

Compare to Prilosec OTC ®*

Omeprazole
Delayed-Release Tablets
20 mg

Acid Reducer

Treats FREQUENTHeartburn!
Occuring 2 Or More Days A Week

24 HR

One 14-day course of treatment
May take 1 to 4 days for full effect

14TABLETS

 

omeprazole-14s-carton


label-front-panel


label-back-panel

OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 68401960MK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
SUCROSE (UNII: C151H8M554)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize14mm
FlavorImprint Code H;O9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83324-011-141 in 1 CARTON05/10/2024
114 in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:83324-011-423 in 1 CARTON05/10/2024
214 in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21173205/10/2024
Labeler - CHAIN DRUG MARKETING ASSOCIATION, INC. (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Hetero Labs Limited Unit III676162024manufacture(83324-011)

Revised: 4/2024
Document Id: 164b1d0f-ad03-40dd-e063-6394a90a6771
Set id: da09aac6-8fce-448b-98ba-1fc9bce42075
Version: 2
Effective Time: 20240417
 
CHAIN DRUG MARKETING ASSOCIATION, INC.