Sun Mark Tussin DM

Manufacturer
A-S Medication Solutions
Effective date
2021-04-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:46

Label at a glance#

ProductSun Mark Tussin DM cough and chest congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and administration

• do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL every 4 hours children under 12 years do not use

Storage and handling

• each 10 mL contains: sodium 6 mg • store at 20-25°C (68-77°F). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

cough lasts for 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children

12 years and over

10 mL every 4 hours

children under 12 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4290

NDC: 50090-4290-0 118 mL in a BOTTLE / 1 in a CARTON

Dextromethorphan Hydrobromide, Guaifenesin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4290-02023-01-30C16284748780-1f386c64a-39d9-0266-e053-dadaa90a7c1aMcKesson Tussin DM Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4290-0Sun Mark Tussin DMcough and chest congestion118 mL in 1 BOTTLESOLUTION1183
50090-4290-0Sun Mark Tussin DMcough and chest congestion1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4290SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210418_e6d57e60-39f3-461a-b1d7-81f62ef57837.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-017-34ML - Milliliter49348-017dc120335-7736-48e7-aa3c-8654f547d9db12012-07-24
49348-017-37ML - Milliliter49348-0179578848d-f65a-4c98-b197-e0583922ac7212012-07-24
49348-017-39ML - Milliliter49348-017cb098ba1-c27c-4eac-bf4a-0508ad76139b12012-07-24

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
50090-429050090-4290-0
49348-017

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
8be05fbc-2849-469d-aeab-c456454e1a98e6d57e60-39f3-461a-b1d7-81f62ef578372021-04-16WarningsExact identifier
spl id: 8be05fbc-2849-469d-aeab-c456454e1a98
spl set id: e6d57e60-39f3-461a-b1d7-81f62ef57837

Reported adverse events (FAERS/openFDA)#

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