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dg health omeprazole

Dolgencorp, LLC Omeprazole Drug Facts

Approved
Approval ID

326bf21c-fad4-473e-9e7f-797319d4353a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

Dolgencorp, LLC

DUNS: 068331990

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 Code55910-915
Application NumberNDA022032
Product Classification
M
Marketing Category
C73594
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (14)

OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MONOETHANOLAMINEInactive
Code: 5KV86114PT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARATEInactive
Code: QU7E2XA9TG
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/14/2024

Principal Display Panel

DG™|health

Bonus! 14 FREE

Compare to Prilosec OTC®

Omeprazole

Delayed Release Tablets 20 mg

Acid Reducer

Treats Frequent Heartburn!

24 HR

THIS ITEM IS ELECTRONICALLY PROTECTED

28 Tablets

Actual Tablet Size

Two 14-Day Courses of Treatment

May take 1 to 4 days for full effect

Omeprazole Carton Image 1

Omeprazole Carton Image 2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/14/2024

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/5/2013

Active ingredient (in each tablet)

Omeprazole 20 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/1/2009

Purpose

Acid reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 11/14/2024

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 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).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/9/2018

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 2/5/2013

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: 6/1/2009

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/9/2018

Questions or comments?

1-888-309-9030

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dg health omeprazole - FDA Drug Approval Details