CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablets 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:

Strategic Sourcing Services LLC

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 TABLETS TABLET,
FILM
COATED
STRATEGIC SOURCING SERVICES LLC
----------
CETIRIZINE HYDROCHLORIDE TABLETS
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET)
Cetirizine HCl, 10mg
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 antihistaminecontaining 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.
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° to 25°C (68° to 77°F)
INACTIVE INGREDIENTS
hypromellose, lactose monohydrate, magnesium stearate, polyethylene
glycol, povidone,
starch, titanium dioxide.
QUESTIONS?
call 1-888-375-3784.
PRINCIPAL DISPLAY PANEL
300 ct Carton
PRINCIPAL DISPLAY PANEL
300 ct Container label
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablets tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN