Your browser does not support JavaScript! ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [MSD CONSUMER CARE, INC.]
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ZEGERID OTC (omeprazole and sodium bicarbonate) capsule
[MSD Consumer Care, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Drug Facts

Active ingredients (in each capsule)Purpose
Omeprazole 20 mgAcid reducer
Sodium Bicarbonate 1100 mgAllows 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 (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

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.

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 blue band around the capsule is missing or broken. Do not use if foil under cap, printed 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 dioxide

Questions or comments?

Call 1-888-ZEG-OTC (1-888-493-4682) between 8:00AM and 5:00PM Central Standard Time, Monday through Friday or visit www.ZegeridOTC.com

© Copyright & Distributed by MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA,
a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 42 Capsule Carton

NDC 11523-7265-3

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

Principal Display Panel - 42 Capsule Carton
ZEGERID OTC 
omeprazole and sodium bicarbonate capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7265
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Omeprazole (Omeprazole) Omeprazole20 mg
Sodium Bicarbonate (Bicarbonate Ion) Sodium Bicarbonate1100 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium 
FD&C blue No. 1 
gelatin 
magnesium stearate 
polysorbate 80 
titanium dioxide 
Product Characteristics
ColorWHITE (with blue band) Scoreno score
ShapeCAPSULESize23mm
FlavorImprint Code ZEG;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7265-11 in 1 CARTON
114 in 1 BOTTLE
2NDC:11523-7265-33 in 1 CARTON
214 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02228104/01/2010
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 8/2013
 
MSD Consumer Care, Inc.

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