Histanaz

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: Histanaz
Generic name: PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE
Manufacturer: Capital Pharmaceutical, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 3e87d0f3-f16c-5972-e063-6294a90acc8a
SPL ID: 5013a487-2901-ef02-e063-6394a90a2902
Version: 2
Effective date: 2026-04-22
Source export date: 2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:27:26

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 number		M012	openfda.application_number
brand name		Histanaz	openfda.brand_name
generic name		PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE	openfda.generic_name
manufacturer name		Capital Pharmaceutical, LLC	openfda.manufacturer_name
ndc	package	29978-129-10	openfda.package_ndc
ndc	product	29978-129	openfda.product_ndc
ndc11	package	29978012910	derived:openfda.package_ndc
rxcui		2727351	openfda.rxcui
spl id		5013a487-2901-ef02-e063-6394a90a2902	id
spl set id		3e87d0f3-f16c-5972-e063-6294a90acc8a	set_id
unii		R35D29L3ZA	openfda.unii
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 exceed recommended dosage. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.