CETIRIZINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)

Available from:

Mylan Pharmaceuticals 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, FILM COATED
MYLAN PHARMACEUTICALS INC.
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Cetirizine hydrochloride USP, 5 mg
PURPOSE
Antihistamine
USES
temporarily relieves these symptoms due to hay fever or other upper
respiratory
allergies:
•
•
•
•
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
•
•
•
•
STOP USE AND ASK A DOCTOR IF
an allergic reaction to this product occurs. Seek medical help right
away.
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 PREGNANT OR BREAST-FEEDING:
•
•
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 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
Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium
stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol, sodium
lauryl sulfate,
titanium dioxide, and triacetin
QUESTIONS?
Call 1-877-446-3679 (1-877-4-INFO-RX)
MANUFACTURED FOR:
MYLAN PHARMACEUTICALS INC.
Morgantown, WV 26505
PRINCIPAL DISPLAY PANEL - 5 MG ALLERGY
NDC 0378-3635-01
CETIRIZINE HCL
TABLETS, USP
ALLERGY
5 MG
ANTIHISTAMINE
INDOOR & OUTDOOR ALLERGIE