Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameCETIRIZINE HYDROCHLORIDE
Labeler / manufacturerJones Healthcare Group - Packaging Services, Inc
RouteORAL
Drug classDrug class not supplied in source label
Product NDC67414-012
Label effective date2026-08-24
Official product label reference
Zyrtec Allergy Cetirizine HCl — Jones Healthcare Group - Packaging Services, Inc
This page contains 15 source sections for CETIRIZINE HYDROCHLORIDE, oral route. Label set 59cf7672-fdde-ddbd-e063-6394a90a223b, version 1.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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
Purpose
Purpose Antihistamine
Dosage and administration — label text
Directions adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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 kidney disease ask a doctor
Table text from source:
| adults and children 6 years and over | one 10 mg capsule once daily; do not take more than one 10 mg capsule 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 kidney disease | ask a doctor
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. 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)
Unclassified section
Drug Facts
Other information • store between 20° to 25°C (68° to 77°F) • avoid high humidity and excessive heat above 40°C (104°F) • protect from light • do not use if foil inner seal printed with “Sealed For Your Safety” is broken or missing
Active ingredient
Active ingredient (in each capsule) Cetirizine HCl 10 mg Purpose Antihistamine
Do not use
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
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
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
While using this medicine
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
When to stop use and seek help
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy or breast feeding
If pregnant or breast-feeding: • if breast-feeding: not recommended. • if pregnant: ask a health professional before use.
Child safety
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)
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.