ZEGERID OTC- omepraole, sodium bicarbonate capsule, gelatin coated 
Riley Consumer Care LLC

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Riley Consumer Care LLC DBA Carlin Consumer Healthcare Drug Facts

Active ingredients (in each capsule)

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg…. Allows absorption of this omeprazole product

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
a sodium-restricted diet

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

14-Day Course of Treatment

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 (in 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

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

FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

Questions or comments?

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

Package/Label Principal Display Panel

CLINICALLY PROVEN TO Treat Frequent Heartburn

Zegerid OTC®

● Omeprazole 20mg/Acid Reducer

● Sodium Bicarbonate 1100mg/Allows Absorption of this Omeprazole Product

14 CAPSULES

24 HOUR

One 14-Day Course of Treatment

MAY TAKE 1 TO 4 DAYS FOR FULL EFFECT

Zegerid OTC Carton Image 1
Zegerid OTC Carton Image 2
ZEGERID OTC 
omepraole, sodium bicarbonate capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82632-699
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (BLUE BAND) Scoreno score
ShapeCAPSULESize23mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82632-699-011 in 1 CARTON01/10/2024
114 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:82632-699-031 in 1 CARTON01/10/2024
242 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20136101/10/2024
Labeler - Riley Consumer Care LLC (118598784)

Revised: 1/2024
Document Id: 8d00c19a-d86b-4a2f-8791-b320ad3ca781
Set id: 8d00c19a-d86b-4a2f-8791-b320ad3ca781
Version: 1
Effective Time: 20240126
 
Riley Consumer Care LLC