Crcle Cetirizine Hydrochloride
Crcle Cetirizine Hydrochloride is an FDA drug label for the active ingredient CETIRIZINE HYDROCHLORIDE manufactured by Innovus Pharmaceuticals, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230421.
Generic: CETIRIZINE HYDROCHLORIDE
Manufacturer: Innovus Pharmaceuticals, Inc.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 57483-250
Application: ANDA209274
Effective: 20230421
Active Ingredients: Active ingredient (in each tablet) Cetirizine HCl 10 mg
Indications & Usage
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
Dosage & Administration
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
Contraindications
Not available.
Warnings
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)
Adverse Reactions
Not available.
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