FDA Label for Omeprazole And Sodium Bicarbonate

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 20-25^oC (68-77^oF)
• •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

NEW

ACID REDUCER

Omeprazole & Sodium Bicarbonate Capsules 20 mg / 1100 mg

Acid Reducer

Allows Absorption of this Omeprazole Product

Treats frequent heartburn

42 CAPSULES

Actual Size

Compare to Zegerid OTC® active ingredients

THREE 14-DAY COURSES OF TREATMENT