sinus 12 hour

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: sinus 12 hour
Generic name: PSEUDOEPHEDRINE HCL
Manufacturer: L. Perrigo Company
Product type: HUMAN OTC DRUG
SPL set ID: 26206f75-648f-47c9-8bad-25127c33961d
SPL ID: 98b199af-35e9-4582-9d3f-129d0696172f
Version: 4
Effective date: 2025-10-03
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:10:44

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	075153	derived:openfda.application_number
application number		ANDA075153	openfda.application_number
brand name		sinus 12 hour	openfda.brand_name
generic name		PSEUDOEPHEDRINE HCL	openfda.generic_name
manufacturer name		L. Perrigo Company	openfda.manufacturer_name
ndc	package	0113-2017-60	openfda.package_ndc
ndc	product	0113-2017	openfda.product_ndc
ndc11	package	00113201760	derived:openfda.package_ndc
rxcui		1049154	openfda.rxcui
spl id		98b199af-35e9-4582-9d3f-129d0696172f	id
spl set id		26206f75-648f-47c9-8bad-25127c33961d	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.