CETIRIZINE HYDROCHLORIDE 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:

Cardinal Health 107, LLC

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:

Product summary:

Cetirizine Hydrochloride Tablets, USP are available as follows: 10 mg - White, film-coated, round, biconvex, beveled edge, unscored tablets debossed with M on one side of the tablet and C37 on the other side. Available overbagged with 10 tablets per bag, NDC 55154-5399-0. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: MH/DRUGS/25/NKD/89 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Distributed By: Cardinal Health Dublin, OH 43017 L48853561223 S-12769 10/21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
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DRUG FACTS
CETIRIZINE HCL
10 MG TABLETS, USP
ANTIHISTAMINE
INDOOR & OUTDOOR ALLERGIES
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR
SHOW ANY SIGNS OF TAMPERING.
ACTIVE INGREDIENT (IN EACH TABLET)
Cetirizine Hydrochloride, USP 10 mg
PURPOSE
Antihistamine
USES
temporarily relieves these symptoms due to hay fever or other upper
respiratory
allergies:
•
•
•
•
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
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
•
•
•
•
STOP USE AND ASK A DOCTOR IF
an allergic reaction to this product occurs. Seek medical help right
away.
IF PREGNANT OR BREAST-FEEDING:
•
•
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS (24 HOUR RELIEF)
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
•
INACTIVE INGREDIENTS
Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium
stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol, sodium
lauryl sulfate,
titanium dioxide, and triacetin
QUESTIONS? 1-800-848-0462
•
drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
if breast-feeding: not recommended
if pregnant: ask a h