Active Ingredient (In Each Caplet)
Cetirizine HCl 10 mg
Cetirza Tablet
FDA Label NDC 50332-0154
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hart Health for the product Cetirza (NDC 50332-0154). 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 caplet), purpose, uses, warnings, ask doctor if you have, ask doctor or pharmacist before use if you are, when using this product, stop use and ask doctor, 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
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 Doctor If You Have
- liver or kidney disease.
Ask Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
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 Doctor
if an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast Feeding
If pregnant or breast-feeding, 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 12 years and over:
- Take one tablet once daily
- Do not take more than one tablet in 24 hours.
Children under 12 years of age: ask a doctor
Other Information
- do not use if blister unit is broken or torn
- store at 59° to 86°F (15°-30°C)
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
* Please review the disclaimer below.
