Loratadine Allergy Relief

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 Allergy Relief
Generic name: LORATADINE
Manufacturer: Marlex Pharmaceuticals, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: ec08a6ee-3d71-0fa9-e053-2995a90a9cb1
SPL ID: 43e1e645-7da5-86de-e063-6394a90a7f3a
Version: 4
Effective date: 2025-11-18
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:34:17

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	076134	derived:openfda.application_number
application number		ANDA076134	openfda.application_number
brand name		Loratadine Allergy Relief	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		Marlex Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	10135-763-30	openfda.package_ndc
ndc	package	10135-763-03	openfda.package_ndc
ndc	package	10135-763-90	openfda.package_ndc
ndc	product	10135-763	openfda.product_ndc
ndc11	package	10135076330	derived:openfda.package_ndc
ndc11	package	10135076390	derived:openfda.package_ndc
ndc11	package	10135076303	derived:openfda.package_ndc
rxcui		311372	openfda.rxcui
spl id		43e1e645-7da5-86de-e063-6394a90a7f3a	id
spl set id		ec08a6ee-3d71-0fa9-e053-2995a90a9cb1	set_id
unii		7AJO3BO7QN	openfda.unii

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).

Reported adverse events (FAERS/openFDA)#

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