LEVOCETIRIZINE DIHYDROCHLORIDE- levocetirizine dihydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)

Available from:

Micro Labs Limited

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine   temporarily relieves these symptoms due to hay fever or other respiratory allergies: - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat - if you have kidney disease - if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCETIRIZINE DIHYDROCHLORIDE - LEVOCETIRIZINE DIHYDROCHLORIDE TABLET
MICRO LABS LIMITED
----------
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET)
Levocetirizine dihydrochloride USP 5 mg
PURPOS E
Antihistamine
US ES
temporarily relieves these symptoms due to hay fever or other
respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
WARNINGS
DO NOT USE
if you have kidney disease
if you have ever had an allergic reaction to this product or any of
its ingredients or to an
antihistamine containing cetirizine
ASK A DOCTOR BEFORE USE IF YOU HAVE
ever had trouble urinating or emptying your bladder
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
you have trouble urinating or emptying your bladder
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).
DO NOT USE
if you have kidney disease
if you have ever had an allergic reaction to this product or any of
its ingredients or to an
antihistamine containing cetirizine
ASK A DOCTOR OR PHARMACIST BEFORE USE IF
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
adults 65 years of age and older
ask a doctor
adults and children 12-64 years of age
take 1 tablet (5 mg) once daily in the evening
do not take more than1 tablet (5 mg) in 24 hours
½ tablet (2.5 mg) once daily in the evening may
be appropriate for less severe symptoms
children 6-11 years of age
take ½ tablet (2.5 mg) once daily in the evening
do not take more than ½ tablet (2.5 mg) in 24
hours
children under 6 years of age
do not use
consumers with kidney disease
do not use
STORAGE
store between 20° and 25°C (68° and 77°F)
safety sealed: do not use if