FDA.reportPublic FDA data

Loratadine antihistamine

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
Loratadine antihistamine
Generic name
LORATADINE
Manufacturer
NuCare Pharmaceuticals,Inc.
Product type
HUMAN OTC DRUG
SPL set ID
54b37bcc-a8b0-0c17-e054-00144ff8d46c
SPL ID
2b4e1a74-38aa-956a-e063-6294a90ae2f1
Version
6
Effective date
2025-01-09
Source export date
2026-08-17
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/0b1cc8680154603ac269ec69e1c6611714d626104ff688eca4b2c067b511bd72/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:50:14
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 do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, 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)