Omeprazole And Sodium Bicarbonate Capsule, Gelatin Coated
FDA Label NDC 41250-938

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Omeprazole And Sodium Bicarbonate (NDC 41250-938). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each capsule), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each Capsule)

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Package/label Principal Display Panel

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 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 (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 20-25^°C (68-77^°F)
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