Zegerid Otc Capsule
FDA Label NDC 82632-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Riley Consumer Care Llc for the product Zegerid Otc (NDC 82632-100). 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 otc - active ingredient, use, warnings, do not use if you have:, ask a doctor before use if you have, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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.
  • omeprazole may cause severe skin reactions
    Symptoms may include:
    • skin reddening
    • blisters
    • rash
      • If an allergic reaction occurs, stop use and seek medical help right away

Do Not Use If You Have:

  • trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • 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

    • 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.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • a sodium-restricted diet.

Otc - Ask Doctor/Pharmacist

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 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

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?

Call 1-888-4-ZEG-OTC (1-888-493-4682) between: 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday

Zegerid OTC design logo is a registered trademark of Riley Consumer Care, LLC d/b/a Carlin Consumer Health

Zegerid OTC is a registered trademark of Santarus, Inc.

Dist by: Riley Consumer Care, LLC d/b/a Carlin Consumer Health
New York, NY 10151

Package Label.Principal Display Panel

HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN

Zegerid OTC works differently from other OTC heartburn products, such as antacids and other 
acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces 
stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days.

TIIPS FOR MANAGING HEARTBURN
  • Do not lie flat or bend over after eating
  • Do not eat late at night or just before bedtime
  • Certain foods or drinks are more likely to cause heartburn,
    such as rich, spicy, fatty and fried foods, chocolate, caffeine,
    alcohol and even some fruits and vegetables 
  • Eat slowly and do not eat big meals
  • If you are overweight, lose weight
  • If you smoke, quit smoking
  • Raise the head of your bed
  • Wear loose-fitting clothing around your stomach

CLINICALLY PROVEN TO
Treat Frequent Heartburn

Zegerid 
OTC®

  • Omperazole 20mg / Acid Reducer
  • Sodium Bicarbonate 1100mg
    /Allows Absorption of this
    Omperazole Product

    • 14 CAPSULES

    One 14-Day Course of Treatment
    MAY TAKE 1 TO 14 DAYS FOR FULL EFFECT

    24 HOUR

    1H9D5 XL C1

    Carton (Carton)

    Carton (Carton)

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