FDA Label for Cetirizine
View Indications, Usage & Precautions
Cetirizine Product Label
The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Cetirizine HCl 5mg
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 a 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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Use only with enclosed dosing cup:
Adults and children 6 years and over: 1 teaspoonful (5ml) or 2 teaspoonfuls (10ml) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10ml) in 24 hours.
Adults 65 years and over: 1 teaspoonful (5mo) once daily; do not take more than 1 teaspoonful (5ml) in 24 hours.
Children 2 to under 6 years of age:
1/2 teaspoonful (2.5ml) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5mo) once daily or 1/2 teaspoonful (2.5ml) every 12 hours. Do not give more than 1 teaspoonful (5ml) in 24 hours.
Children under 2 years of age: ask a doctor
Consumers with liver or kidney disease: ask a doctor
Other Information
Do not use if carton is opened, or if printed neckband is broken or missing.
Questions or comments?
Call 1-800-719-9260
Store between 20° to 25°C (68° to 77°F)
Dosing cup should be washed and left to air dry after each use.
Inactive Ingredients
acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water
Distributed by:
AmerisourceBergen
Valley Forge, PA 19482-0959
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Package/Label Principal Display Panel
* Please review the disclaimer below.