Zegerid OTC
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each capsule)
Omeprazole 20 mg
Sodium Bicarbonate 1100 mg
OTC - PURPOSE SECTION
Purpose
Acid reducer
Allows absorption of this omeprazole product
INDICATIONS & USAGE SECTION
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 SECTION
Warnings
Allergy alert: Do not use if you are allergic to omeprazole
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
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.
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-1222).
Directions
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
Other information
● each tablet 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 INGREDIENT SECTION
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
42 count carton
Treats Frequent Heartburn
Zegerid OTC ®
• Omeprazole 20 mg/Acid Reducer • Sodium Bicarbonate 1100 mg/ Allows Absorption of this Omeprazole Product
42 CAPSULES
Three 14-Day Courses of Treatment