Label: ZEGERID OTC- omeprazole and sodium bicarbonate capsule
- NDC Code(s): 11523-7265-1, 11523-7265-3
- Packager: MSD Consumer Care, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each capsule) Purpose Omeprazole 20 mg Acid reducer Sodium Bicarbonate 1100 mg Allows absorption of this omeprazole product
- 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.
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 (immune system medicine)
- prescription antiretrovirals (medicines for HIV infection)
- any other prescription drugs. Sodium bicarbonate may interact with certain prescription drugs
Stop use and ask 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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- 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.Close
- 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
croscarmellose sodium, FD&C blue No. 1, gelatin, magnesium stearate, pharmaceutical ink, polysorbate 80, titanium dioxideClose
- Questions or comments?
Call 1-888-4-ZEG-OTC (1-888-493-4682) between 8:00AM and 5:00PM Central Standard Time, Monday through Friday or visit www.ZegeridOTC.comClose
- SPL UNCLASSIFIED SECTION
© Copyright & Distributed by MSD Consumer Care, Inc.,Close
PO Box 377, Memphis, TN 38151 USA,
a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.
- PRINCIPAL DISPLAY PANEL - 42 Capsule Carton
Treats Frequent Heartburn
• Omeprazole 20 mg/Acid Reducer
• Sodium Bicarbonate 1100 mg/
Allows Absorption of this Omeprazole Product
Three 14-Day Courses of Treatment
- INGREDIENTS AND APPEARANCE
omeprazole and sodium bicarbonate capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7265 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Omeprazole (UNII: KG60484QX9) (Omeprazole - UNII:KG60484QX9) Omeprazole 20 mg Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate 1100 mg Inactive Ingredients Ingredient Name Strength croscarmellose sodium (UNII: M28OL1HH48) FD&C blue No. 1 (UNII: H3R47K3TBD) gelatin (UNII: 2G86QN327L) magnesium stearate (UNII: 70097M6I30) polysorbate 80 (UNII: 6OZP39ZG8H) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (with blue band) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code ZEG;20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-7265-1 1 in 1 CARTON 1 14 in 1 BOTTLE 2 NDC:11523-7265-3 3 in 1 CARTON 2 14 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022281 04/01/2010 Labeler - MSD Consumer Care, Inc. (968091715)