Leader Nasal Decongestant

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: Leader Nasal Decongestant
Generic name: PSEUDOEPHEDRINE HCL
Manufacturer: Cardinal Health 110, LLC. dba Leader
Product type: HUMAN OTC DRUG
SPL set ID: 25609b66-047c-46e7-bc95-20eb8e6c9617
SPL ID: 62f921b0-d768-4905-b4f5-990e89031788
Version: 4
Effective date: 2024-09-20
Source export date: 2026-10-22
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-22/1160cc7c18a51aae8b212960fb7d994421b216feaf877dbb4e35618e03bacded/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run: 20261023T001338Z
Imported at: 2026-10-23 01:29:46

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Leader Nasal Decongestant	openfda.brand_name
generic name		PSEUDOEPHEDRINE HCL	openfda.generic_name
manufacturer name		Cardinal Health 110, LLC. dba Leader	openfda.manufacturer_name
ndc	package	70000-0002-1	openfda.package_ndc
ndc	package	70000-0002-2	openfda.package_ndc
ndc	product	70000-0002	openfda.product_ndc
ndc11	package	70000000201	derived:openfda.package_ndc
ndc11	package	70000000202	derived:openfda.package_ndc
rxcui		1049160	openfda.rxcui
spl id		62f921b0-d768-4905-b4f5-990e89031788	id
spl set id		25609b66-047c-46e7-bc95-20eb8e6c9617	set_id
unii		6V9V2RYJ8N	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 are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever 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.