Zegerid OTC contains a combination of omeprazole and sodium bicarbonate. Omeprazole is a proton pump inhibitor that 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.

Zegerid OTC is used to treat frequent heartburn that occurs on 2 or more days a week. It not intended for the immediate relief of heartburn.

It may take 1 to 4 days for Zegerid OTC to have full effect.

The omeprazole in Zegerid OTC can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Omeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

This medicine contains sodium bicarbonate, a form of salt. Tell your doctor if you have Bartter's syndrome (a rare kidney disorder), or if you are on a low-salt diet.

Take Zegerid OTC exactly as prescribed by your doctor or pharmacist. Follow all directions on the product label and read all medication guides or instruction sheets.

Zegerid OTC is for short-term use only. Take one capsule every day for 14 days only. 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.

Take this medicine on an empty stomach, at least 1 hour before eating a meal.

Take the Zegerid OTC capsule with a full glass of water. Do not use any other type of liquid or food. Swallow the capsule whole and do not crush, chew, break, or open it.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Gastroesophageal Reflux Disease:

Omeprazole 20 mg orally once a day
-Duration of therapy: Up to 14 days

Comments:
-The OTC formulation course of treatment may be repeated every 4 months as necessary.
-The full effect of treatment may not be reached for up to 4 days.

Uses:
Treatment of frequent heartburn occurring at least 2 days a week.

You should not take Zegerid OTC if you are allergic to omeprazole or sodium bicarbonate, or if you are also taking any medication that contains rilpivirine (Edurant, Juluca, Complera, Odefsey).

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

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 diet, you may not be able to use Zegerid OTC. Talk with your doctor.

To make sure Zegerid OTC is safe for you, tell your doctor or pharmacist if you have::

• a rare kidney disorder called Bartter's syndrome;

• liver disease;

• any allergies;

• heart failure;

• problems with acid-base (pH) balance in your body;

• low levels of calcium, magnesium, or potassium levels in your blood;

• if you are of Asian descent.

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Ask a doctor or pharmacist before using this medicine if you are pregnant or breastfeeding.

Zegerid OTC is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include confusion, headache, drowsiness, blurred vision, fast heartbeats, sweating, vomiting, dry mouth, and warmth or tingling.

This medicine can cause diarrhea, which may be a sign of a gastrointestinal infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

If you take this medicine long-term, ask your doctor if you should also use calcium supplements. Also ask your doctor about sources of calcium in your diet from milk or other dairy products. Getting too much calcium while taking Zegerid OTC may be harmful to your kidneys.

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

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• new or unusual pain in your wrist, back, hip, or thigh;

• muscle twitching or tremor;

• numbness or tingling in your face, arms, or legs;

• confusion, dizziness;

• a seizure;

• low magnesium - dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling;

• kidney problems - little or no urination, blood in your urine, swelling, rapid weight gain;

• new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight; or

• vitamin B12 deficiency - shortness of breath, feeling lightheaded, irregular heartbeats, muscle weakness, pale skin, tiredness, mood changes.

Common Zegerid OTC side effects may include:

• headache;

• nausea, vomiting, stomach pain, gas; or

• diarrhea.

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.

Tell your doctor about all your current medicines. Many drugs can interact with omeprazole and sodium bicarbonate, especially:

• clopidogrel;

• cyclosporine;

• digoxin;

• methotrexate;

• rifampin; or

• St. John's wort.

This list is not complete and many other drugs may affect Zegerid OTC. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.