CETIRIZINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Granules USA, Inc.

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 if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. liver or kidney disease. Your doctor should determine if you need a different dose. taking tranquilizers or sedatives. an allergic reaction to this product occurs. Seek medical help right away.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE TABLET
GRANULES USA, INC.
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CETIRIZINE HYDROCHLORIDE TABLETS, USP 10 MG
ANTIHISTAMINE
24 HOUR
INDOOR & OUTDOOR ALLERGIES
ACTIVE INGREDIENT
(in each tablet)
Cetirizine HCl 10 mg
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
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
■ 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. (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° to 25°C (68° to 77°F)
■ contains no ingredient made from a gluten-containing grain (Wheat,
barley or rye)
INACTIVE INGREDIENTS
colloidal silicon dioxide, croscarmellose sodium, hypromellose,
lactose monohydrate,
magnesium stearate, microcrystalline