Zegerid OTC

Generic Name: omeprazole and sodium bicarbonate
Date of Approval: December 1, 2009
Company: Merck & Co. and Santarus Inc.
Treatment for: Heartburn

FDA Approves Zegerid OTC

The U.S. Food and Drug Administration (FDA) has approved Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules), for over-the-counter treatment of frequent heartburn.

Zegerid OTC is a proton pump inhibitor (PPI), the strongest and most effective class of acid-reducing medications available for frequent heartburn. Zegerid OTC treats frequent heartburn by controlling and suppressing acid for a full 24 hours, all day and all night. Zegerid OTC contains a patented dual-ingredient formulation that combines the prescription acid reducing medicine (omeprazole) with sodium bicarbonate, which protects the omeprazole from acid in the stomach.

What is Zegerid OTC?

Zegerid OTC contains a combination of omeprazole and sodium bicarbonate. Omeprazole decreases the amount of acid your stomach produces. Sodium bicarbonate is an antacid that raises the pH in your stomach to keep the omeprazole from breaking down in stomach acid.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Zegerid OTC is used to treat frequent heartburn (heartburn that occurs 2 or more days a week).

Important information

Zegerid OTC can change the way your body absorbs or eliminates certain other drugs. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Zegerid OTC contains sodium bicarbonate, a form of salt. Each capsule contains the equivalent of 303 mg of sodium. If you are on a low-salt or low-sodium diet, you may not be able to use Zegerid OTC. Talk with your doctor.

Take Zegerid OTC with water on an empty stomach, at least 1 hour before eating a meal.

Before taking this medicine

Allergy alert: Do not use if you are allergic to omeprazole.

Do not use Zegerid OTC if you have:

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

These may be signs of a more serious condition. See your doctor.

Ask your doctor before using Zegerid OTC if you have:

  • heartburn more than 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

Zegerid OTC contains sodium bicarbonate, a form of salt. Each capsule contains the equivalent of 303 mg of sodium. If you are on a low-salt or low-sodium diet, you may not be able to use Zegerid OTC. Talk with your doctor.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Omeprazole can pass into breast milk and may harm a nursing baby. Do not use Zegerid OTC without telling your doctor if you are breast-feeding a baby.

How should I take Zegerid OTC?

Directions for Use

  • for use in adults 18 years of age and older
  • this product is to be used once a day (every 24 hours), every day for 14 days
  • Zegerid OTC is not intended for the immediate relief of heartburn. 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 one capsule with a full glass of water at least one hour before eating in the morning
  • take every day for 14 days
  • do not take more than one capsule a day
  • swallow whole, do not crush or chew 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 four months
  • do not take for more than 14 days or more often than every four 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.

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 one course of treatment every 4 months

Take Zegerid OTC only as directed. Do not take it in larger doses or for longer than recommended. Always follow the directions on package label.

Store this medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, drowsiness, blurred vision, fast heartbeat, sweating, dry mouth, nausea or vomiting.

Zegerid OTC side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • easy bruising or bleeding, unusual weakness; or
  • fast, slow, or uneven heartbeat.

Less serious Zegerid OTC side effects may include:

  • headache;
  • nausea, stomach pain; or
  • diarrhea or constipation;white patches or sores inside your mouth or on your lips;
  • mild fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Zegerid OTC?

Ask a doctor or pharmacist before use if you are taking:

  • warfarin (blood-thinning medicine)
  • clopidogrel (used to prevent blood clots)
  • prescription antifungal or anti-yeast medicines
  • diazepam (anxiety medicine)
  • digoxin (heart medicine)
  • phenytoin (seizure medicine)
  • tacrolimus (immune system medicine)
  • prescription antiretrovirals (medicines for HIV infection)
  • any other prescription drugs. Sodium bicarbonate may interact with certain prescription drugs

Where can I get more information?

Your pharmacist can provide more information about Zegerid OTC.

Other Information

  • 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
  • Keep out of the reach of children.

Inactive Ingredients

croscarmellose sodium, FD&C blue No. 1, gelatin, magnesium stearate, pharmaceutical ink, polysorbate 80, titanium dioxide

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