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:

Sandoz Inc

INN (International Name):

CETIRIZINE HYDROCHLORIDE

Composition:

CETIRIZINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE TABLET
SANDOZ INC
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DRUG FACTS
ACTIVE INGREDIENT
(in each tablet)
Cetirizine HCl 5 mg
PURPOS E
Antihistamine
KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control
Center right away.
US ES
Temporarily relieves these symptoms due to hay fever or other upper
respiratory allergies:
•
•
•
•
WARNINGS
DO NOT USE if you have ever had an allergic reactions 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
•
•
•
•
STOP USE AND ASK A DOCTOR if an allergic reaction to this product
occurs. Seek medical help right away.
IF PREGNANT OR BREAST-FEEDING:
•
•
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help
or contact a Poison Control
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
if breast-feeding: not recommended
if pregnant: ask a health professional before use.
Center right away.
DIRECTIONS
adults and children 6 years and over
1 to 2 tablets once daily; depending upon severity
of symptoms; do not take more than 2 tablets in 24
hours
adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in
24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
OTHER INFORMATION
•
INACTIVE INGREDIENTS
Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium
stearate, povidone and titanium
dioxide.
QUESTIONS? 1-800-525-8747
Manufactured in India by Sandoz Private Ltd.,
for Sandoz Inc., Princeton, NJ 08540
Rev.06/2013
PRINCIPAL DISPLAY PANEL
NDC 0781-1683-64
CETIRIZINE HCL TAB