FDA.reportPublic FDA data

Claritin

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
Claritin
Generic name
LORATADINE
Manufacturer
R J General Corporation
Product type
HUMAN OTC DRUG
SPL set ID
a34e8cb7-4fdf-45be-b288-45d93eef6220
SPL ID
43c8f3f3-5cc5-a286-e063-6294a90a6192
Version
4
Effective date
2025-11-17
Source export date
2026-08-08
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/8e6fb5103b1ab4ab5de5645b4a27f29a2c2739cd9369b81b7befcfa3734d8ef4/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:41:38
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 if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. your doctor should determine if you need a different dose. When using this product don not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask 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.