ZANTAC 360- famotidine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)

Available from:

Chattem, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acid reducer ■ 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 food and beverages   Acid reducer ■ 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 food and beverages

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZANTAC 360- FAMOTIDINE TABLET, FILM COATED
CHATTEM, INC.
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ZANTAC 360
_ZANTAC 360⁰_
_FAMOTIDINE TABLETS 10 MG / ACID REDUCER_
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH TABLET)_
Famotidine USP 10 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 food and beverages
_WARNINGS_
ALLERGY ALERT: Do not use if you are allergic to famotidine 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
■ kidney disease
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking a prescription drug. Acid reducers may interact with certain
prescription drugs.
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)
_DIRECTIONS_
■ adults and children 12 years and over:
■ to RELIEVE symptoms, swallow 1 tablet with a glass of water. Do
not chew.
■ to PREVENT symptoms, swallow 1 tablet with a glass of water at any
time
from 15 TO 60 MINUTES BEFORE eating food or drinking beverages that
cause
heartburn
■ do not use more than 2 tablets in 24 hours
■ children under 12 years: ask a docto