CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE- cetirizine hcl, pseudoephedrine hcl tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine Nasal Decongestant

Product summary:

Product: 50090-1098 NDC: 50090-1098-1 1 TABLET, EXTENDED RELEASE in a BLISTER PACK / 24 in a CARTON NDC: 50090-1098-0 30 TABLET, EXTENDED RELEASE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE-
CETIRIZINE HCL, PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE
A-S MEDICATION SOLUTIONS
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PERRIGO CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
DRUG
FACTS
ACTIVE INGREDIENTS (IN EACH EXTENDED RELEASE TABLET)
Cetirizine HCl 5 mg
Pseudoephedrine HCl 120 mg
PURPOSE
Antihistamine
Nasal Decongestant
USES
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WARNINGS
DO NOT USE
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ASK A DOCTOR BEFORE USE IF YOU HAVE
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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
nasal congestion
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose
if you have ever had an allergic reaction to this product or any of
its ingredients or
to an antihistamine containing hydroxyzine.
if you are now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain
drugs for depression, psychiatric, or emotional conditions, or
Parkinson’s disease),
or for 2 weeks after stopping the MAOI drug. If you do not know if
your
prescription drug contains an MAOI, ask a doctor or pharmacist before
taking this
product.
heart disease
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ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking tranquilizers or sedatives.
WHEN USING THIS PRODUCT
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STOP USE AND ASK A DOCTOR IF
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IF PREGNANT OR BREAST-FEEDING:
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KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
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adults and children 12 years
and over
take 1 tablet every 12 hours; do not take more than 2
tablets in 24 hours.
adults 65 years and over
ask a doctor
children under 12 years of age ask a doctor
consumers with liver or kidney
disease
ask a doctor
OTHER INFORMATION
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thyroid disease
diabetes
glaucoma
high blood pressure
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your do