Ranitidine Hydrochloride

FDA Drug Profile — Ranitidine Hydrochloride, Acid Reducer

Ranitidine Hydrochloride is listed in the FDA National Drug Code directory with 11 NDC codes, marketed under brand names including Ranitidine Hydrochloride, Acid Reducer. Available dosage forms: powder, capsule, tablet, film coated.

Drug Details

Generic Name
Ranitidine Hydrochloride
Brand Names
Ranitidine Hydrochloride, Acid Reducer
Application Number
ANDA075742
Sponsor
Dr. Reddy's Laboratories Limited
NDC Codes
11
Dosage Forms
POWDER, CAPSULE, TABLET, FILM 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).