FAMOTIDINE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SPIRIT PHARMACEUTICALS,LLC

INN (International Name):

FAMOTIDINE

Composition:

FAMOTIDINE 10 mg

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMOTIDINE- FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE
SPIRIT PHARMACEUTICALS,LLC
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HEARTBURN RELIEF
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET)
Famotidine USP 10mg
PURPOS E
Acid reducer
US ES
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
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. Do not
chew.
to PREVENT symptoms, swallow 1 tablet with a glass of water 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 doctor
OTHER INFORMATION
store at 25°-30°C (77°-86°F).
read the directions and warnings before use
protect from moisture.
keep the carton and package insert. They contain important
information.
INACTIVE INGREDIENTS
hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium
stearate, microcrystalline