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omeprazole

Walgreen Co. Omeprazole Drug Facts

Approved
Approval ID

2fc3704c-daac-3e18-e063-6394a90a47ea

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Sixarp, LLC

DUNS: 016329513

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Omeprazole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59368-308
Application NumberNDA022032
Product Classification
M
Marketing Category
C73594
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (19)

MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
MONOETHANOLAMINEInactive
Code: 5KV86114PT
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARATEInactive
Code: QU7E2XA9TG
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CARMINIC ACIDInactive
Code: CID8Z8N95N
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE, UNSPECIFIEDInactive
Code: A7ZHS2RJ34
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/4/2024

Package/Label Principal Display Panel

Treats frequent heartburn!

Walgreens

Compare to Prilosec OTC ®

WALGREENS PHARMACIST RECOMMENDED

Omeprazole

DELAYED RELEASE TABLETS 20 mg / ACID REDUCER

24 HR

42 TABLETS

THREE 14-DAY COURSES OF TREATMENT

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

SWALLOW – DO NOT CHEW

20

ACTUAL SIZE

Wildberry Mint coated tablet

cartonOmeprazole Carton Image 2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/4/2024

Use

  • treats frequent heartburn (occurs2 or moredays a week)
  • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/2/2015

Active ingredient (in each tablet)

Omeprazole 20 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/2/2015

Purpose

Acid reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 3/4/2024

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 withlightheadedness, sweating or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequentchest 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).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/4/2024

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 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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 4/2/2015

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 4/2/2015

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/4/2024

Questions or comments?

1-800-719-9260

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