OMEPRAZOLE- omeprazole magnesium capsule, delayed release 
Meijer, Inc.

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Meijer Distribution, Inc. Omeprazole Drug Facts

Active ingredient (in each capsule)

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

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 capsule with a glass of water before eating in the morning
take every day for 14 days
do not take more than 1 capsule a day
do not use for more than 14 days unless directed by your doctor
swallow whole. Do not chew or crush capsules.

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
FDA approved dissolution test specifications differ from USP

Inactive ingredients

FD&C yellow # 6, ferric oxide, gelatin, glyceryl monostearate, hypromellose, magnesium stearate, meglumine, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, shellac, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

meijer®

Omeprazole

Delayed Release Capsules, 20 mg | Acid Reducer

COMPARE TO PRILOSEC OTC® ACTIVE INGREDIENT

24 HR

Treats FREQUENT Heartburn!

Mini Capsules

42 CAPSULES

THREE 14-DAY COURSES OF TREATMENT MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

See Current Drug Facts

Actual Size

omeprazole pdp
omeprazole dfl
OMEPRAZOLE 
omeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0281
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MEGLUMINE (UNII: 6HG8UB2MUY)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE, ORANGEScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 24S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79481-0281-014 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2023
2NDC:79481-0281-13 in 1 CARTON08/24/2023
214 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21609608/24/2023
Labeler - Meijer, Inc. (006959555)

Revised: 3/2024
Document Id: edbe9a75-73ef-4b53-8f08-10e775091e23
Set id: 0340ef94-d2b4-47af-a045-d0d031293984
Version: 2
Effective Time: 20240329
 
Meijer, Inc.