OMEPRAZOLE- omeprazole tablet, delayed release 
Rite Aid Corporation

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Rite Aid Corporation Omeprazole Drug Facts

Active ingredient (in each tablet)

Omeprazole 20 mg

Purpose

Acid reducer

Use

treats frequent heartburn (occurs 2 or more days 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 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

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, crush, or suck tablets.

Repeated 14-Day Courses (if needed)

you may repeat a14-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 20-25°C (68-77°F) and protect from moisture

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?

1-800-719-9260

Package/Label Principal Display Panel

TREATS FREQUENT HEARTBURN!

Compare to Prilosec OTC®

OMEPRAZOLE

Delayed Release Tablets, 20 mg

ACID REDUCER

ACTUAL SIZE

24HR

WILDBERRY MINT COATED TABLET

SWALLOW – DO NOT CHEW

28 TABLETS

TWO 14-DAY COURSES OF TREATMENT

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

omeprazole image-1
omeprazole image-2
OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0453
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:11822-0453-13 in 1 CARTON03/26/2015
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:11822-0453-21 in 1 CARTON03/20/2017
214 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:11822-0453-32 in 1 CARTON07/27/2023
314 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203203/26/2015
Labeler - Rite Aid Corporation (014578892)

Revised: 11/2023
Document Id: 8841afea-64b7-4a36-8f83-5fa5c9fe1243
Set id: ee853401-b641-4dab-b708-29424c2d0b79
Version: 6
Effective Time: 20231113
 
Rite Aid Corporation