FDA-approved label information
Reproduced from the FDA Structured Product Label via the openFDA API. Label version: May 23, 2025.
- Status
- Human Otc Drug
- Brand names
- Ranitidine
- Route
- Oral
Indications and usage
Use(s) relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
Warnings (older label format)
Warnings Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.These may be signs of a serious condition. See your doctor. with other acid reducers 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 kidney disease 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 doctor if your heartburn continues or worsens you need to take this product for more than 14 days 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).
Source: US Food and Drug Administration, via the openFDA API. The FDA does not review, endorse or verify third-party reproductions of this data, and label information may have been updated since it was retrieved.
Read the current full label on DailyMed
FDA approval applies to the uses listed on the label. Approval status in your country may differ.