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 HCL
Manufacturer: A-S Medication Solutions
Product type: HUMAN OTC DRUG
SPL set ID: 204849d1-ac4b-4dbe-8769-fcb30291f880
SPL ID: 32a348b0-eed2-48cf-b609-cc7e7ea19e08
Version: 10
Effective date: 2023-10-31
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:24:06

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		pseudoephedrine hydrochloride	openfda.brand_name
generic name		PSEUDOEPHEDRINE HCL	openfda.generic_name
manufacturer name		A-S Medication Solutions	openfda.manufacturer_name
ndc	package	50090-5615-1	openfda.package_ndc
ndc	package	50090-5615-0	openfda.package_ndc
ndc	product	50090-5615	openfda.product_ndc
ndc11	package	50090561500	derived:openfda.package_ndc
ndc11	package	50090561501	derived:openfda.package_ndc
rxcui		1049160	openfda.rxcui
spl id		32a348b0-eed2-48cf-b609-cc7e7ea19e08	id
spl set id		204849d1-ac4b-4dbe-8769-fcb30291f880	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.