CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Apotex Corp.

Toedieningsweg:

ORAL

Prescription-type:

OTC DRUG

therapeutische indicaties:

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

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED
APOTEX CORP.
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DRUG FACTS
_ACTIVE INGREDIENT (IN EACH TABLET)_
Cetirizine HCl, USP 10
_PURPOSE_
Antihistamine
_USES_
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 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 and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in
24 hours.
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_
store between 20° and 25°C (68° - 77°F)
do not use if seal under bottle cap is broken or missing
meets USP Dissolution Test 3
_INACTIVE INGREDIENTS_
carnauba wax, hypromellose, lactose monohydrate, magnesiumstearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, starch (corn) and titanium dioxide.
_QUESTIONS OR COMMENTS?_
Call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time
PRINCIPAL DISPLAY PANEL
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