OMEPRAZOLE- omeprazole tablet, delayed release 
Walgreen Company

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Walgreen Co. Omeprazole Delayed Release Tablets 20mg Drug Facts

Active ingredient (in each tablet)

Omeprazole 20 mg

Purpose

Acid reducer

Uses

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

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 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 20-25°C (68-77°F) and protect from moisture

Inactive ingredients

carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Prilosec OTC®

Omeprazole

DELAYED RELEASE TABLETS 20 mg / ACID REDUCER

TABLETS

24 HR

Treats frequent heartburn!

28 TABLETS

TWO 14-DAY COURSES OF TREAMENT

ACTUAL SIZE

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

SEE CURRENT DRUG FACTS

915-94-omeprazole.jpg
OMEPRAZOLE 
omeprazole tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0915
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorBROWNScoreno score
ShapeOVALSize12mm
FlavorImprint Code 20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0915-302 in 1 CARTON02/27/2008
114 in 1 CARTON
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0363-0915-553 in 1 CARTON02/27/2008
214 in 1 CARTON
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0363-0915-7414 in 1 CARTON02/27/200804/01/2013
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0363-0915-011 in 1 CARTON10/06/2010
414 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0363-0915-033 in 1 CARTON03/25/2011
514 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02203202/27/2008
Labeler - Walgreen Company (008965063)

Revised: 5/2019
Document Id: 99202ce8-79bd-42b3-94f2-7ae019f6b6ba
Set id: 30a893d2-198a-4184-81b4-02399324ff29
Version: 6
Effective Time: 20190515
 
Walgreen Company