Tusnel Pediatric

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: Tusnel Pediatric
Generic name: DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL
Manufacturer: Llorens Pharmaceutical International Division
Product type: HUMAN OTC DRUG
SPL set ID: 82f447f6-4f1b-4f56-9d7d-ea02adeea88c
SPL ID: 47461ad3-a121-2a11-e063-6294a90a0f8f
Version: 9
Effective date: 2025-12-31
Source export date: 2026-10-30
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:58:57

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Tusnel Pediatric	openfda.brand_name
generic name		DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	openfda.generic_name
manufacturer name		Llorens Pharmaceutical International Division	openfda.manufacturer_name
ndc	package	54859-544-16	openfda.package_ndc
ndc	package	54859-544-04	openfda.package_ndc
ndc	product	54859-544	openfda.product_ndc
ndc11	package	54859054404	derived:openfda.package_ndc
ndc11	package	54859054416	derived:openfda.package_ndc
rxcui		1098911	openfda.rxcui
spl id		47461ad3-a121-2a11-e063-6294a90a0f8f	id
spl set id		82f447f6-4f1b-4f56-9d7d-ea02adeea88c	set_id
unii		9D2RTI9KYH	openfda.unii
unii		6V9V2RYJ8N	openfda.unii
unii		495W7451VQ	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.

Reported adverse events (FAERS/openFDA)#

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