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Omeprazole and sodium bicarbonate

Dosage form: capsule, gelatin coated
Ingredients: OMEPRAZOLE 20mg, SODIUM BICARBONATE 1100mg
Labeler: H E B
NDC Code: 37808-732

HEB OMEPRAZOLE AND SODIUM BICARBONATE Drug Facts

Active ingredients (in each capsule)

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

Purpose

Acid reducer

Allows absorption of this omeprazole product

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

Do not use if you have:
trouble or pain swallowing food
vomiting with blood
bloody or black stools

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.
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
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
warfarin, clopidogrel or cilostazol (blood-thinning medicines)
prescription antifungal or anti-yeast medicines
diazepam (anxiety medicine)
digoxin (heart medicine)
tacrolimus or mycophenolate mofetil (immune system medicines)
prescription antiretrovirals (medicines for HIV infection)
methotrexate (arthritis medicine)
any other prescription drugs. Sodium bicarbonate 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

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 (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
each capsule contains: sodium 303 mg
read the directions, warnings and accompanying label information before use
store at 20-25oC (68-77oF)
tamper-evident: do not use if the band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing.
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?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Zegerid OTC® active ingredients

OMEPRAZOLE AND SODIUM BICARBONATE Capsules, 20 mg/1100 mg

Omeprazole, 20mg/Acid Reducer

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

Treats Frequent Heartburn

ACTUAL SIZE

3 BOTTLES – 14 CAPSULES EACH TOTAL 42 CAPSULES

GLUTEN FREE

Three 14-day courses of treatment

OMEPRAZOLE AND SODIUM BICARBONATE 
omeprazole, sodium bicarbonate capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-732
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE20 mg
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE1100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
GELATIN 
POLYSORBATE 80 
SODIUM LAURYL SULFATE 
SODIUM STEARYL FUMARATE 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (blue band) Scoreno score
ShapeOVALSize23mm
FlavorImprint Code732
Contains    
Packaging
#Item CodePackage Description
1NDC:37808-732-011 BOTTLE in 1 CARTON
114 CAPSULE, GELATIN COATED in 1 BOTTLE
2NDC:37808-732-033 BOTTLE in 1 CARTON
214 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20136108/25/2017
Labeler - H E B (007924756)

Revised: 08/2017
 
H E B

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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