FDA.reportPublic FDA data

Tussnex FM Severe cough and congestion

Manufacturer
Guardian Drug Company
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:23

Label at a glance#

ProductTussnex FM Severe cough and congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

hepls loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold

Dosage and administration

do not take more than 6 doses in 24-hour period measure only with dosing coup provided do not use dosing cup with other products dose as follows or as directed by a doctor Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours Children under 12 years of age: Do not use

Storage and handling

each 20 mL contains: sodium 20 mg store between 15-30 o C(59-86 o F) do not refrigerate dosing cup provided

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • hepls loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
  • nasal congestion due to a cold

Warnings

WARNINGS SECTION

Do not use

  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in 24-hour period
  • measure only with dosing coup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours
  • Children under 12 years of age: Do not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 20 mg
  • store between 15-30oC(59-86oF)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, edetate disodium, FDand C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compare to the active ingredients in Mucinex Fast Max Severe Cough and congestion

Maximum strength Tussnex FM

Severe Cough and Congestion

Dextromethorphan HBr

Cough Suppressant

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal Decongestant

Relieves:

Soothes cough

Thins and loosens mucus

Relieves Nasal and chest congestion

For ages 12 and over

SNSN

NMNM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN5
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD5
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY5
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-617-58Tussnex FM Severe cough and congestion177 mL in 1 BOTTLELIQUID1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-617TUSSNEX FM SEVERE COUGH AND CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY]5Current NDC, Legacy NDC, 1 package rows20241222_387df403-7803-4031-915e-8de9b103a162.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V921
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53041-61753041-617-58

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 222 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / ORAL84 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii+route
38 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92CAPSULE / ORAL7 mgExact identifier — unii+route
12 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
38 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii+route
44 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
36 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACONCENTRATE / ORAL0.04 mg/1mlExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / ORAL84 mgExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92SUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
12 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
36 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii+route
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92TABLET / ORAL7 mgExact identifier — unii+route
12 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION, EXTENDED RELEASE / ORAL62 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
36 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
36 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
36 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii+dosage form
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates

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
Tussnex FM Severe cough and congestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company387df403-7803-4031-915e-8de9b103a1622024-12-19WarningsExact identifier
ndc (package): 53041-617-58
ndc (product): 53041-617
ndc11 (package): 53041061758
spl id: cfe109cb-2cbb-4929-84f6-5b4fe970e0c9
spl set id: 387df403-7803-4031-915e-8de9b103a162

Reported adverse events (FAERS/openFDA)#

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