CETIRIZINE HYDROCHLORIDE- 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:

Rugby Laboratories, Inc.

INN (International Name):

CETIRIZINE HYDROCHLORIDE

Composition:

CETIRIZINE HYDROCHLORIDE 10 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 - 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
RUGBY LABORATORIES, INC.
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Cetirizine HCl 10 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
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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
take 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
lactose monohydrate, magnesium stearate, polyvinyl alcohol,
polyethylene glycol, povidone, starch,
talc, titanium dioxide.
QUESTIONS OR COMMENTS?
CALL 1-877-753-3935 MONDAY-FRIDAY 9AM-5PM EST
PRINCIPAL DISPLAY PANEL
Compare to Active Ingredient in ZYRTEC®*
Original Prescription Strength
ALLERGY RELIEF
CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg
ANTIHISTAMINE
ALLERGY
Indoor and Outdoor Allergies
24 hour