Tusnel Cough Suppressant Expectorant

Manufacturer
Llorens Pharmaceutical International Division, Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:30:30

Label at a glance#

ProductTusnel Cough Suppressant Expectorant
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

In each 5 mL

Dextromethorphan - 10 mg

Guaifenesin - 100 mg

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive

WARNINGS SECTION

Warnings

Do not use if you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product.

Do not useif you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or head that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeing, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222)right away.

DOSAGE & ADMINISTRATION SECTION

Directions: 

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
 Age Dose
 Adults and children over 12 years and over 2 teaspoonfuls (10 mL)
 Children under 12 years do not use

INACTIVE INGREDIENT SECTION

Inactive ingredients cherry flavor, citric acid, FD&C #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

OTC - QUESTIONS SECTION

Questions or comments? 1-866-595-5598

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TusnelTussinTusnelTussin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-509-16Tusnel Cough Suppressant Expectorant473 mL in 1 BOTTLELIQUID4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-509-16ML - Milliliter54859-509c710a6f2-4893-4233-9200-88fd2ec455f012025-12-16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54859-50954859-509-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tusnel Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.af71cdbc-33d6-4303-b494-d7321721d3be2025-12-31WarningsExact identifier
ndc (package): 54859-509-16
ndc (product): 54859-509
ndc11 (package): 54859050916
spl id: 4746270d-593c-472a-e063-6294a90ace21
spl set id: af71cdbc-33d6-4303-b494-d7321721d3be

Reported adverse events (FAERS/openFDA)#

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