Omeprazole And Sodium Bicarbonate Capsule, Gelatin Coated
FDA Label NDC 37808-732

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Omeprazole And Sodium Bicarbonate (NDC 37808-732). 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 active ingredients (in each capsule), purpose, use, warnings, do not use if you have:, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 20-25oC (68-77oF)
  • 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

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Compare to Zegerid OTC® active ingredients

OMEPRAZOLE AND SODIUM BICARBONATE Capsules, 20 mg/1100 mg

Omeprazole, 20mg/Acid Reducer

Sodium Bicarbonate, 1100 mg/Allows Absorption of this Omeprazole Product

Treats Frequent Heartburn

ACTUAL SIZE

3 BOTTLES – 14 CAPSULES EACH TOTAL 42 CAPSULES

GLUTEN FREE

Three 14-day courses of treatment

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