FDA.reportPublic FDA data

DOMETUSS-DM

Manufacturer
Domel Laboratories
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:01:19

Label at a glance#

ProductDOMETUSS-DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves coughs due to minor throat and bronchial irritation as may occur with a cold.

Dosage and administration

Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.      Adults and children 12 years of age and over  Take 1 teaspoonful (5 mL) every 6 hours  Children 6 to under 12 years of age  Take 1/2 teaspoonful (2.5 mL) every 6 hours  Children under 6 years of age  Ask a doctor  

Label contents#

Full prescribing information#

Drug FactsActive ingredients (in each 5 mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200mg

Dextromethorphan HBr 30 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Cough suppressant

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.

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves coughs due to minor throat and bronchial irritation as may occur with a cold.

Warnings

WARNINGS SECTION

  • Do not exceed recommended dosage.
  • A persistant cough may be a sign of a serious condition; if cough persists for more than one week, tend to recur, or is accompanied by fever, rash, or persistant headache, consult a doctor.

Do not use this product

OTC - DO NOT USE SECTION

  • for persistant or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
  • If you are now taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; if you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

as a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.

 

 
 Adults and children 12 years of age and over Take 1 teaspoonful (5 mL) every 6 hours
 Children 6 to under 12 years of age Take 1/2 teaspoonful (2.5 mL) every 6 hours
 Children under 6 years of age Ask a doctor

 

Other Information

OTHER SAFETY INFORMATION

• store at room temperature 15°-30°C (59°-86°F).

Tamper Evident: Do not use if there is evidence of tampering.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Artificial grape flavor, citric acid, D&C red #33, FD&C blue #1, glycerin, methyl paraben (as preserative), propylene glycol, propyl paraben (as preseratie, purified water, sodium citrate, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

Please call (787) 767-3246

DOMETUSS-DM product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53809-201-01

DOMETUSS-DM

EXPECTORANT/COUGH SUPPRESSANT

Alcohol and Sugar

FREE

Grape Flavoe

1 Fl. Oz.

Rev: 10/13

Lot#:/EXP.DATE:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

Domel Dometuss 201Domel Dometuss 201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147924dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 5 mL Oral SolutionPSN4
1147924dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML Oral SolutionSCD4
1147924dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG per 5 ML Oral SolutionSY4

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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53809-201-012025-05-20C16284748780-12cef2736-968b-d83d-e063-dadaa90ab31fDOMETUSS-DM
53809-201-042025-05-20C16284748780-12cef2736-968b-d83d-e063-dadaa90ab31fDOMETUSS-DM
53809-201-012025-01-30C16284748780-12cef2736-968b-d83d-e063-dadaa90ab31fDOMETUSS-DM
53809-201-042025-01-30C16284748780-12cef2736-968b-d83d-e063-dadaa90ab31fDOMETUSS-DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53809-201-01DOMETUSS-DM30 mL in 1 BOTTLELIQUID304
53809-201-04DOMETUSS-DM118 mL in 1 BOTTLELIQUID1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53809-201DOMETUSS-DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DOMEL LABORATORIES]4Legacy NDC, 2 package rows20250522_7c4e7eca-0dc2-4b49-bda5-d61770ef9aca.zip

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
53809-20153809-201-01, 53809-201-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

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
02354652-4696-45cc-94d0-d82092b0de8b7c4e7eca-0dc2-4b49-bda5-d61770ef9aca2024-12-05WarningsExact identifier
spl id: 02354652-4696-45cc-94d0-d82092b0de8b
spl set id: 7c4e7eca-0dc2-4b49-bda5-d61770ef9aca

Reported adverse events (FAERS/openFDA)#

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