ZEGERID OTC

Manufacturer
RILEY CONSUMER CARE, LLC | Aurohealth LLC
Effective date
2024-10-11
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:34

Label at a glance#

ProductZEGERID OTC
Active ingredientOMEPRAZOLE, SODIUM BICARBONATE
Label structure19 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, although some people get complete relief of symptoms within 24 hours

Label contents#

Full prescribing information#

Active ingredients (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole 20 mg
Sodium Bicarbonate 1100 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer
Allows absorption of this omeprazole product

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
  • nausea or vomiting
  • stomach pain
  • a sodium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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,

WARNINGS 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 (1-800-222-1222).

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, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

SPL UNCLASSIFIED SECTION

  • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
  • take every day for 14 days
  • do not take more than 1 capsule a day
  • do not chew or crush the capsule
  • do not open capsule and sprinkle on food
  • do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

SPL UNCLASSIFIED SECTION

  • 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

  • each capsule contains: sodium 303 mg
  • read the directions, warnings and accompanying label information before use 
  • store at 20° - 25°C (68° - 77°F)
  • tamper-evident: do not use if the blue band around the capsule is missing or broken. Do not use if foil inner seal imprinted with "Sealed for your protection" is missing, open or broken.
  • keep product out of high heat and humidity
  • protect product from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, croscarmellose sodium, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, polysorbate 80, potassium sorbate, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide.

Questions or comments?

SPL UNCLASSIFIED SECTION

Call 1-888-4-ZEG-OTC (1-888-493-4682) between 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday

SPL UNCLASSIFIED SECTION

HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN

Zegerid OTC works differently from other OTC heartburn products, such as antacids and other acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days.


TIPS FOR MANAGING HEARTBURN

  • Do not lie flat or bend over soon after eating
  • Do not eat late at night or just before bedtime
  • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables
  • Eat slowly and do not eat big meals
  • If you are overweight, lose weight
  • If you smoke, quit smoking
  • Raise the head of your bed
  • Wear loose-fitting clothing around your stomach

Dist by:
Riley Consumer Care, LLC
d/b/a Carlin
Consumer Health
New York, NY 10151

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY PROVEN TO
Treat Frequent Heartburn

Zegerid
OTC®

 

Omeprazole &
Sodium Bicarbonate
Capsules 20 mg / 1100 mg

ACID REDUCER/
ALLOWS ABSORPTION OF THIS OMEPRAZOLE PRODUCT

14
CAPSULES

ONE 14-DAY COURSE OF TREATMENT

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY PROVEN TO
Treat Frequent Heartburn

Zegerid
OTC®

 

Omeprazole &
Sodium Bicarbonate
Capsules 20 mg / 1100 mg

ACID REDUCER/
ALLOWS ABSORPTION OF THIS OMEPRAZOLE PRODUCT

24 HOUR

14
CAPSULES


One 14-Day Course of Treatment

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Carton Label)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN2
646344Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006PSN2
646344omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SBD2
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD2
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY2
646344Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SY2
646344Zegerid (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule, Reformulated Aug 2006SY2
646344Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121
OMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82632-101-01ZEGERID OTC1 in 1 CARTONCAPSULE12
82632-101-01ZEGERID OTC14 in 1 BOTTLECAPSULE142
82632-101-03ZEGERID OTC14 in 1 BOTTLECAPSULE142
82632-101-03ZEGERID OTC3 in 1 CARTONCAPSULE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82632-101ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [RILEY CONSUMER CARE, LLC]24 package rows20241020_dfed6561-212a-4afa-a929-4d80cdfcdef3.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82632-10182632-101-01, 82632-101-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
eef665d7-2b12-4d76-bebe-a751e7cd07acdfed6561-212a-4afa-a929-4d80cdfcdef32024-10-11WarningsExact identifier
spl id: eef665d7-2b12-4d76-bebe-a751e7cd07ac
spl set id: dfed6561-212a-4afa-a929-4d80cdfcdef3

Reported adverse events (FAERS/openFDA)#

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