CETIRIZINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Physicians Total Care, 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: - 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, FILM
COATED
PHYSICIANS TOTAL CARE, INC.
----------
DRUG FACTS
ACTIVE INGREDIENT
Cetirizine Hydrochloride 5 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.
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
store between 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENTS
anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium
stearate, microcrystalline
cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate,
titanium dioxide, and triacetin
QUES TIONS ?
call 1-877-446-3679
MYLAN PHARMACEUTICALS INC.
MORGANTOWN, WV 26505
PRINCIPAL DISPLAY PANEL - 5 MG HIVES RELIEF
NDC 54868-5855-0
Cetirizine Hydrochloride
Tablets 5 mg
ant
                                
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