Cetirizine Hydrochloride 10 mg

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 10 mg
Generic name
CETIRIZINE HYDROCHLORIDE 10 MG
Manufacturer
Contract Pharmacal Corp.
Product type
HUMAN OTC DRUG
SPL set ID
84459f11-3405-4a8e-be38-333b7de2a578
SPL ID
3633ac85-4814-e6a7-e063-6294a90a375d
Version
2
Effective date
2025-05-28
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:28
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

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 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 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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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