Topcare Childrens All Day Allergy

Topcare Childrens All Day Allergy is an FDA drug label for the active ingredient CETIRIZINE HCL manufactured by Topco Associates LLC 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 20191121.

Generic: CETIRIZINE HCL

Manufacturer: Topco Associates LLC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 36800-189

Application: ANDA204226

Effective: 20191121

Active Ingredients: Active ingredient (in each 5 mL) Cetirizine HCl 5 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 • use only with enclosed dosing cup • find right dose on chart below • mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information • store between 20 ° to 25 ° C (68 ° to 77 ° F) • do not use if carton is opened, or if printed neckband is broken or missing • see bottom panel for lot number and expiration date

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.

Adverse Reactions

Not available.

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