omepraole, sodium bicarbonate
Drug Details
- Generic Name
- omepraole, sodium bicarbonate
- Brand Names
- Zegerid OTC
- Application Number
- ANDA201361
- Sponsor
- Riley Consumer Care LLC
- NDC Codes
- 1
- Dosage Forms
- CAPSULE, GELATIN COATED
- Routes
- ORAL
- Active Ingredients
- OMEPRAZOLE, SODIUM BICARBONATE
Indications and Usage
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
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 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 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).