SinuLief

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: SinuLief
Generic name: LORATADINE
Manufacturer: RoseWell Pharmaceuticals LLC
Product type: HUMAN OTC DRUG
SPL set ID: 32619143-a782-3497-e063-6394a90aaaec
SPL ID: 4084b4ad-91cf-9487-e063-6394a90a3cbe
Version: 2
Effective date: 2025-10-06
Source export date: 2026-10-27
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:48:38

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		SinuLief	openfda.brand_name
generic name		LORATADINE	openfda.generic_name
manufacturer name		RoseWell Pharmaceuticals LLC	openfda.manufacturer_name
ndc	package	85510-101-01	openfda.package_ndc
ndc	product	85510-101	openfda.product_ndc
ndc11	package	85510010101	derived:openfda.package_ndc
rxcui		311372	openfda.rxcui
spl id		4084b4ad-91cf-9487-e063-6394a90a3cbe	id
spl set id		32619143-a782-3497-e063-6394a90aaaec	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

Drug label_only 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. I pregnant or breast-feeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or 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.