CETIRIZINE HYDROCHLORIDE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

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Ficha técnica Ficha técnica (SPC)
21-05-2021

Ingredientes activos:

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

Disponible desde:

Ohm Laboratories Inc.

Designación común internacional (DCI):

CETIRIZINE HYDROCHLORIDE

Composición:

CETIRIZINE HYDROCHLORIDE 10 mg

Vía de administración:

ORAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

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

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

                                CETIRIZINE HYDROCHLORIDE- CETIRIZINE HYDROCHLORIDE TABLET
OHM LABORATORIES INC.
----------
CETIRIZINE HYDROCHLORIDE
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET)
Cetirizine HCl, USP 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
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 (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
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING
FROM BOTTLE.
store between 20° to 25° C (68° to 77° F)
INACTIVE INGREDIENTS
corn starch, hypromellose, lactose monohydrate, magnesium stearate,
polyethylene
glycol, povidone, talc, titanium dioxide
QUESTIONS?
call 1-800-406-7984
Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901
PRINCIPAL DISPLAY PANEL - 10 MG TABLET BOTTLE LABEL
NDC 51660-939-53
                                
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