Active Ingredient (In Each Tablet)
Ceitirizine HCL 10mg
Cetirizine Tablet
FDA Label NDC 51316-764
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Cetirizine (NDC 51316-764). 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 (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
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
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)
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 ■ ask a doctor
kidney disease
Other Information
■ store between 20° and 25°C (68° and 77°F)
■ contains no ingredient made from a gluten-containing grain (Wheat, barley or rye)
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, titanium dioxide
Questions?
Call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
* Please review the disclaimer below.
