FDA.reportPublic FDA data

FDA label bf4ea7e6-9d64-13e5-e053-2a95a90a5a1e

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)

SPL set ID
bc7ca2d2-0813-199e-e053-2a95a90a811a
SPL ID
bf4ea7e6-9d64-13e5-e053-2a95a90a5a1e
Version
5
Effective date
2021-04-06
Source export date
2026-08-01
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/2026-08-01/206e0852f7011b53c21719ec5c68ac6752381d0fcd1d348f7428adad64429e89/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:17:22

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

WARNINGS AND PRECAUTIONS: Do not exceed the recommended dosage. If you are taking other medicines, consult your doctor. Do not use loratadine with alcohol or other central nervous system depressants. Children under 12 years old: do not use PEDIATRIC USE: Children under 12 years of age: do not use. PREGNANCY AND BREASTFEEDING: Do not use during pregnancy or breastfeeding. CONTRAINDICATIONS: Do not use in case of hypersensitivity to the ingredients. ADVERSE REACTIONS: Fatigue, headache, dry mouth, nausea, gastritis, skin rash. ACCIDENTAL INGESTION AND OVERDOSE: Reported symptoms in case of overdose: sleepiness, tachycardia, headache. The treatment that should be started immediately is symptomatic and adjuvant. Keep out of reach of children. If symptoms persist for more than 5 days, consult your doctor. Do not store above 86°F. Keep this container tightly closed.

warnings and cautions

WARNINGS AND PRECAUTIONS: Do not exceed the recommended dosage. If you are taking other medicines, consult your doctor. Do not use loratadine with alcohol or other central nervous system depressants. Children under 12 years old: do not use PEDIATRIC USE: Children under 12 years of age: do not use. PREGNANCY AND BREASTFEEDING: Do not use during pregnancy or breastfeeding. CONTRAINDICATIONS: Do not use in case of hypersensitivity to the ingredients. ADVERSE REACTIONS: Fatigue, headache, dry mouth, nausea, gastritis, skin rash. ACCIDENTAL INGESTION AND OVERDOSE: Reported symptoms in case of overdose: sleepiness, tachycardia, headache. The treatment that should be started immediately is symptomatic and adjuvant. Keep out of reach of children. If symptoms persist for more than 5 days, consult your doctor. Do not store above 86°F. Keep this container tightly closed.