OMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS

Manufacturer
P & L Development, LLC
Effective date
2023-11-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:32:15

Label at a glance#

ProductOmeprazole
Active ingredientOMEPRAZOLE MAGNESIUM
Label structure16 sections

Dosage and administration

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 everyday for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless dir...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Omeprazole delayed-release tablet 20 mg

(equivalent to 20.6 mg omeprazole magnesium)     

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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:

OTC - DO NOT USE SECTION

  • 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:

OTC - ASK DOCTOR SECTION

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss    Ÿ
  • nausea or vomiting  
  • stomach pain

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug.

Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 everyday 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

SPL UNCLASSIFIED SECTION

  • read the directions and warnings before use
  • Keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F) and protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, dextrose, FD&C Blue #2, FD&C Red #40, flavor, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polyvinyl alcohol, propylene glycol, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Tips for Managing Heartburn

SPL UNCLASSIFIED SECTION

  • Do not lie flat or bend over after eating
  • Do not wear tight-fitting clothing around the stomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Prilosec® OTC

Omeprazole

Delayed-release tablets 20 mg

Acid reducer

Treats FREQUENT heartburn 24 HR

SWALLOW-DO NOT CHEW

Tablets

One 14-day course of treatment

May take 1 to 4 days for full effect

Coated with Wildberry Flavor

Manufactured for:

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acid Reducer Wildberry Flavor
Acid Reducer Wildberry Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN1
402014omeprazole 20 MG Delayed Release Oral TabletSCD1
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-408-14Omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE11
59726-408-14Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE141
59726-408-28Omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE11
59726-408-28Omeprazole28 in 1 CARTONTABLET, DELAYED RELEASE281
59726-408-42Omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE11
59726-408-42Omeprazole42 in 1 CARTONTABLET, DELAYED RELEASE421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-408OMEPRAZOLE TABLET, DELAYED RELEASE [P & L DEVELOPMENT, LLC]16 package rows20241101_679e53fe-9c99-442d-b6ff-4b3628ef4d16.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-40859726-408-14, 59726-408-28, 59726-408-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bb2b08fe-4697-4ed4-adcc-9a5e62701392679e53fe-9c99-442d-b6ff-4b3628ef4d162026-08-10WarningsExact identifier
spl set id: 679e53fe-9c99-442d-b6ff-4b3628ef4d16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.