Country: United States
Language: English
Source: NLM (National Library of Medicine)
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Boehringer Ingelheim Pharmaceuticals Inc.
ranitidine hydrochloride
ranitidine 150 mg
ORAL
OTC DRUG
- 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 - 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 - 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.
New Drug Application
ZANTAC MAXIMUM STRENGTH 150 COOL MINT- RANITIDINE TABLET, COATED BOEHRINGER INGELHEIM PHARMACEUTICALS INC. ---------- ZANTAC 150 COOL MINT TABLETS _DRUG FACTS_ _ACTIVE INGREDIENT (IN EACH TABLET)_ _PURPOSE_ Ranitidine 150 mg (as ranitidine hydrochloride 168 mg ).............................................................................................................................. Acid reducer _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_ 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 if you have kidney disease, except under the advice and supervision of a doctor 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 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. _DIRECTIONS_ adults and children 12 years and over: ® adults and children 12 years and over: to RELIEVE symptoms, swallow 1 tablet with a glass of water to PREVENT symptoms, swallow 1 tablet with a glass of water 30 TO 60 MINUTES BEFORE eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in Read the complete document