Tusnel DM 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 DM Pediatric
Generic name: DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL
Manufacturer: Llorens Pharmaceutical International Division
Product type: HUMAN OTC DRUG
SPL set ID: d915eab8-013e-4ce3-b358-0d531e5ca1ba
SPL ID: 47463023-1b8c-729b-e063-6394a90a8dce
Version: 9
Effective date: 2025-12-31
Source export date: 2026-11-06
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:55:58

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		Tusnel DM Pediatric	openfda.brand_name
generic name		DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	openfda.generic_name
manufacturer name		Llorens Pharmaceutical International Division	openfda.manufacturer_name
ndc	package	54859-603-02	openfda.package_ndc
ndc	product	54859-603	openfda.product_ndc
ndc11	package	54859060302	derived:openfda.package_ndc
rxcui		1241674	openfda.rxcui
spl id		47463023-1b8c-729b-e063-6394a90a8dce	id
spl set id		d915eab8-013e-4ce3-b358-0d531e5ca1ba	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 in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, ask a doctor or pharmacist before giving this product.

Reported adverse events (FAERS/openFDA)#

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