CETIRIZINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Cetirizine Hydrochloride

Composition:

Cetirizine Hydrochloride 10 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE TABLET
TARO PHARMACEUTICALS U.S.A., INC.
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CETIRIZINE HYDROCHLORIDE
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET)
Cetirizine Hydrochloride 10 mg
PURPOS E
Antihistamine
US ES
temporarily relieves these symptoms due to hay fever or other upper
respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
WARNINGS
DO NOT USE if you have ever had an allergic reaction to this product
or any of its ingredients or to an
antihistamine containing hydroxyzine.
ASK A DOCTOR BEFORE USE IF YOU HAVE liver or kidney disease. Your
doctor should determine if you
need a different dose.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking tranquilizers
or sedatives.
WHEN USING THIS PRODUCT
drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
STOP USE AND ASK A DOCTOR IF an allergic reaction to this product
occurs. Seek medical help right away.
IF PREGNANT OR BREAST-FEEDING:
if breast-feeding: not recommended
if pregnant: 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 6 years
one 10 mg tablet once daily; do not take
more than one 10 mg tablet in 24 hours.
and over
A 5 mg product may be appropriate for
less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of
age
ask a doctor
consumers with liver or
kidney disease
ask a doctor
OTHER INFORMATION
DO NOT USE IF CARTON IS OPENED, OR IF IMPRINTED INNER SAFETY SEAL ON
BOTTLE IS BROKEN OR MISSING
store between 20° to 25°C (68° to 77°F)
for lot number and expiry date see carton or bottle label.
INACTIVE INGREDIENTS
corn starch, hypromellose, lactose monohydrate, magnesium stearate,
polyethylene glycol, povidone,
and titanium dioxide.
QUES TIONS ?
Call 1-866-923-4914
Distributed by: TARO PHARMACEUTICAL