Active Ingredient
Cetirizine HCl 5mg
Cetirizine
FDA Label NDC 21695-878
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Cetirizine (NDC 21695-878). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, uses, warnings, directions, other information, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Cetirizine HCl 1mg/ml (5e652955 Bce3 4b0a A754 739712725aaf 01)
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