Pseudoephedrine Hydrochloride

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: Pseudoephedrine Hydrochloride
Generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Manufacturer: STRATEGIC SOURCING SERVICES LLC
Product type: HUMAN OTC DRUG
SPL set ID: 918b2a90-532b-4358-bdff-9ad48c167a7e
SPL ID: 166eaa7e-a180-438e-88b9-6b31bc794b7b
Version: 4
Effective date: 2020-08-11
Source export date: 2026-09-28
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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:14:37

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	077442	derived:openfda.application_number
application number		ANDA077442	openfda.application_number
brand name		Pseudoephedrine Hydrochloride	openfda.brand_name
generic name		PSEUDOEPHEDRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		STRATEGIC SOURCING SERVICES LLC	openfda.manufacturer_name
ndc	package	62011-0306-1	openfda.package_ndc
ndc	product	62011-0306	openfda.product_ndc
ndc11	package	62011030601	derived:openfda.package_ndc
rxcui		1049154	openfda.rxcui
spl id		166eaa7e-a180-438e-88b9-6b31bc794b7b	id
spl set id		918b2a90-532b-4358-bdff-9ad48c167a7e	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.