FDA
Cetirizine Hydrochloride
The FDA lists this product in 17 strengths and forms.
Indications
USE(S) 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 and precautions
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.
Composition
- Active ingredients
- CETIRIZINE HYDROCHLORIDE 10MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- CETIRIZINE HYDROCHLORIDE 5MG/5ML · SolutionANDA090751-001 · Discontinued
- CETIRIZINE HYDROCHLORIDE 5MG/5ML · SolutionANDA078398-001 · Prescription
- CETIRIZINE HYDROCHLORIDE 10MG · TabletThis page
- CETIRIZINE HYDROCHLORIDE 5MG/5ML · SolutionANDA078617-001 · Discontinued
- CETIRIZINE HYDROCHLORIDE 5MG/5ML · SolutionANDA078876-001 · Prescription
- CETIRIZINE HYDROCHLORIDE 5MG/5ML · Solution
At a glance
- Brand name
- Cetirizine Hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Regcon Holdings
- Status
- Over the counter
- FDA approval
- 3 Oct 2024
- Application
- ANDA218895-001