FAMOTIDINE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
26-11-2019

Aktiv ingrediens:

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

Tilgjengelig fra:

Wockhardt USA LLC.

INN (International Name):

FAMOTIDINE

Sammensetning:

FAMOTIDINE 10 mg

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

                                FAMOTIDINE- FAMOTIDINE TABLET
WOCKHARDT USA LLC.
----------
FAMOTIDINE TABLETS USP, 10 MG
OTC - ACTIVE INGREDIENT SECTION
Famotidine USP 10 mg
OTC - PURPOSE SECTION
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
STOP USE AND ASK A DOCTOR IF
● your heartburn continues or worsens
● you need to take this product for more than 14 days
PREGNANCY OR BREAST FEEDING
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
OTC - 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
● read the directions and warnings before use
● store at 25°-30°C (77°-86°F)
● protect from moisture
● keep the carton and package insert. They contain important
information.
INACTIVE INGREDIENT
hydr
                                
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