FDA.reportPublic FDA data

DOMETUSS-DMX

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-DMX
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes Temporarily relieves these symptoms occuring with a cold: nasal congestion, cough due to minor throat and bronchial irritation

Dosage and administration

  Do not exceed recommended dosage Do not take more than 4 doses in any 24-hour period      age  dose  Adults and children 12 years of age and older  1 teaspoon every 6 hours  Children under 12 years of age  ask a doctor  

Label contents#

Full prescribing information#

Drug FactsActive ingredients (in each 5 mL teaspoonful) contains

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200mg

Dextromethorphan HBr, USP 30 mg

Phenylephrine HCL, USP 10 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Cough suppressant

Nasal decongestant

KEEP THIS AND ALL DRUGS OUT OF THE 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 drain bronchial tubes
  • Temporarily relieves these symptoms occuring with a cold: nasal congestion, cough due to minor throat and bronchial irritation

Warnings - Do not use

WARNINGS 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

  • Heart Disease
  • High Blood Pressure
  • Thyroid Disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Cough that lasts or is chronic such as bronchitis or emphysema

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

as a health professional before use.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You get nervous, dizzy, or sleepless
  • Symptoms do not get better within 7 days or are accompanied by a fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.

These could be signs of a serious condition.

Directions

DOSAGE & ADMINISTRATION SECTION

  Do not exceed recommended dosage

Do not take more than 4 doses in any 24-hour period

 

 
 age dose
 Adults and children 12 years of age and older 1 teaspoon every 6 hours
 Children under 12 years of age ask a doctor

 

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Other information

OTHER SAFETY INFORMATION

• Store at 15°-30° C (59°-86°F)

Questions or comments?

OTC - QUESTIONS SECTION

Please call (787) 767-3246

DOMETUSS-DMX product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53809-203-01

DOMETUSS-DMX

COUGH SUPPRESSANT/EXPECTORANT/NASAL DECONGESTANT

Alcohol and Sugar

FREE

Grape Flavor

1 Fl. Oz. (30 mL)

Rev: 12/12

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

LOT#:/EXP.DATE:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

Domel Dometuss 203Domel Dometuss 203

Domel Dometuss 203Domel Dometuss 203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1364914dextromethorphan HBr 30 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN4
1364914dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD4
1364914dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG / phenylephrine hydrochloride 10 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
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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53809-203-012025-05-20C16284748780-12cef2736-9ddf-d83d-e063-dadaa90ab31fDOMETUSS-DMX
53809-203-042025-05-20C16284748780-12cef2736-9ddf-d83d-e063-dadaa90ab31fDOMETUSS-DMX
53809-203-162025-05-20C16284748780-12cef2736-9ddf-d83d-e063-dadaa90ab31fDOMETUSS-DMX
53809-203-012025-01-30C16284748780-12cef2736-9ddf-d83d-e063-dadaa90ab31fDOMETUSS-DMX
53809-203-042025-01-30C16284748780-12cef2736-9ddf-d83d-e063-dadaa90ab31fDOMETUSS-DMX
53809-203-162025-01-30C16284748780-12cef2736-9ddf-d83d-e063-dadaa90ab31fDOMETUSS-DMX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53809-203-01DOMETUSS-DMX30 mL in 1 BOTTLELIQUID304
53809-203-04DOMETUSS-DMX118 mL in 1 BOTTLELIQUID1184
53809-203-16DOMETUSS-DMX473 mL in 1 BOTTLELIQUID4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53809-203DOMETUSS-DMX (GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [DOMEL LABORATORIES]4Legacy NDC, 3 package rows20250522_6949e1c6-df1c-451b-a1e2-9199415440f4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53809-203-04ML - Milliliter53809-2039c618a36-4763-4e66-a25a-8af0d3892d4b12016-02-04

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53809-20353809-203-01, 53809-203-04, 53809-203-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
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
be5556d6-b889-4313-b690-aeabc71d9f746949e1c6-df1c-451b-a1e2-9199415440f42024-12-05WarningsExact identifier
spl id: be5556d6-b889-4313-b690-aeabc71d9f74
spl set id: 6949e1c6-df1c-451b-a1e2-9199415440f4

Reported adverse events (FAERS/openFDA)#

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