CETIRIZINE HYDROCHLORIDE
Summary of product characteristics
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.
Effective Time
20230112
Version
3
Active Ingredient
Active Ingredients (in each tablet) Purpose Cetirizine HCl 10 mg..............................................................................................Antihistimine
Purpose
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
Spl Product Data Elements
CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE MAGNESIUM STEARATE STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TITANIUM DIOXIDE HYPROMELLOSES LACTOSE CTN;10
Application Number
ANDA077829
Brand Name
CETIRIZINE HYDROCHLORIDE
Generic Name
CETIRIZINE HYDROCHLORIDE
Product Ndc
61919-429
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
429
Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask Doctor Or Pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact Poison Control Center right away.
Questions
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 sever 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
Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
When Using
drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary.
Pregnancy Or Breast Feeding
if breast-feeding: not recommended if pregnant: ask a health professional before use.
30 mins
Learning Zones
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Disclaimer
The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).
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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.