Drug label · Respiratory & allergy
Zyrtec — Cetirizine Hydrochloride drug label
openFDA · Retrieved 2026-10-13
Zyrtec label record for cetirizine hydrochloride. The label lists Kenvue Brands LLC as labeler/manufacturer. Route: oral. Includes selected complete prescribing-information sections from openFDA; consult the linked original label for the complete document.
Reference details
- Brand name
- Zyrtec
- Generic name
- CETIRIZINE HYDROCHLORIDE
- Active substance
- CETIRIZINE HYDROCHLORIDE
- Labeler / manufacturer listed
- Kenvue Brands LLC
- Route
- ORAL
- Product type
- HUMAN OTC DRUG
- Application number
- NDA021621
- Label version
- 9
- SPL set ID
- dc613bd5-70fd-1d9b-e053-2995a90a41cd
- Label effective date
- 2026-04-27
- openFDA dataset updated
- 2026-10-13
Indications and usage
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
Warnings
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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. 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)
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 doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using
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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
Stop use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Dosage and administration
Directions may be taken with or without water chew or crush tablets completely before swallowing adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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
Pregnancy or breast feeding
If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use.
Keep out of reach of children
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)
Active ingredient
Active ingredient (in each tablet) Cetirizine HCl 10 mg
Inactive ingredient
Inactive ingredients betadex, corn starch, lactose monohydrate, magnesium stearate, mannitol, silicified microcrystalline cellulose, sucralose
Storage and handling
Other information store between 20° to 25°C (68° to 77°F) do not use if blister unit is torn or broken
Sources and reuse
Selected source label sections. Check the original for the complete label, formatting and latest version.
Selected complete plain-text label sections. Tables and images may require consulting the linked original label. This is a reference copy, not prescribing advice.
Source date: 2026-04-27. Retrieved: 2026-10-13. Text has been organized for reading; this import has not been independently reviewed by a clinician. It is not individualized medical advice.