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:

Carilion Materials Management

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 - 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 - 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.

Product summary:

Product: 68151-2584 NDC: 68151-2584-0 1 TABLET, COATED in a PACKAGE

Authorization status:

New Drug Application

Summary of Product characteristics

ZANTAC 75- RANITIDINE TABLET, COATED
CARILION MATERIALS MANAGEMENT
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ZANTAC 75 DRUG FACTS
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH TABLET)_
_PURPOSE_
Ranitidine 75 mg (as ranitidine hydrochloride 84 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
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:
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 printed foil under bottle cap is open or torn (bottles)
do not use if individual blister unit i