Ranitidine

FDA Drug Profile — Ranitidine cool mint, Ranitidine

Ranitidine is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including Ranitidine cool mint, Ranitidine. Available dosage forms: tablet, capsule, tablet, coated.

Drug Details

Generic Name
Ranitidine
Brand Names
Ranitidine cool mint, Ranitidine
Application Number
ANDA210243
Sponsor
Granules India Ltd
NDC Codes
8
Dosage Forms
TABLET, CAPSULE, TABLET, COATED
Routes
ORAL
Active Ingredients
RANITIDINE HYDROCHLORIDE

Indications and Usage

USES • 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

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 • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • 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 Stop use and ask a 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).