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 HBR, GUAIFENESIN, PHENYLEPHRINE HCL
Manufacturer
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Product type
HUMAN OTC DRUG
SPL set ID
64e36b02-b5be-4d20-8818-cb5b23596671
SPL ID
47463023-1b8d-729b-e063-6394a90a8dce
Version
4
Effective date
2025-12-31
Source export date
2026-11-06
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:36:04
Harmonized routes table
Harmonized routes
ORAL

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 whos is 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 child's prescription drug contains an MAOI: ask your doctor or pharmacist before giving this product. Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes a cough that occurs with too much phlegm a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. When using this product do not exceed the recommended dosage. Stope use and ask doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Reported adverse events (FAERS/openFDA)#

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