Cetirizine Hydrochloride

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Cetirizine Hydrochloride
Generic name
CETIRIZINE HYDROCHLORIDE
Manufacturer
Proficient Rx LP
Product type
HUMAN OTC DRUG
SPL set ID
9c2b97d9-9990-46ab-9027-c34ffb07ce8f
SPL ID
26beeb96-f0b4-4e99-ba9d-3b27c67659dc
Version
3
Effective date
2019-10-01
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:54:17
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: 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/PHARMACIST Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. WHEN USING THIS PRODUCT • drowsines may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinary. STOP USE 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 Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.