ZANTAC 75- ranitidine tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)

Available from:

Navajo Manufacturing Company Inc.

INN (International Name):

RANITIDINE HYDROCHLORIDE

Composition:

RANITIDINE 75 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

• 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

Authorization status:

New Drug Application

Summary of Product characteristics

ZANTAC 75- RANITIDINE TABLET, COATED
NAVAJO MANUFACTURING COMPANY INC.
----------
ZANTAC 75
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH TABLET)_
Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)
_PURPOSE_
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
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, necks 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:
• 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
24 hours)
• do not chew tablet
• children under 12 years: ask a doctor
_OTHER INFORMATION_
• do not use if individual foil pouch is open or torn
• store at 20°-25°C (68°-77°F)
• avoid excessive heat or humidity
• this