FDA.reportPublic FDA data

DOMETUSS-G

Manufacturer
DOMEL
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:40:47

Label at a glance#

ProductDOMETUSS-G
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily reduces cough due to minor throat and bronchial irritation associated with a cold calm the cough control center, and relieves coughing. Temporarily relief nasal congestion due to the common cold hay fever or other upper respiratory allergies sinus congestion and pressure

Dosage and administration

Do not take more than 6 doses in any 24 hours period. Age Dose adults and children 12 years of age and over 1 tablets every 4 hours. children 6 to 12 years of age 1/2 tablet every 4 hours. children under 6 years of age Consult a doctor.

Storage and handling

store at room temperature 15°- 30°C (59° - 86°F). Do not use if there is evidence of tampering.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Guaifenesin200 mgExpectorant
Dextromethorphan HBr20 mgCough Suppressant
Phenylephrine HCl10 mgNasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily reduces cough due to minor throat and bronchial irritation associated with a cold
  • calm the cough control center, and relieves coughing.
  • Temporarily relief nasal congestion due to the common cold
  • hay fever or other upper respiratory allergies
  • sinus congestion and pressure

Warnings

WARNINGS SECTION

  • Do not exceed recommended dosage

If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.

Do not use

OTC - DO NOT USE SECTION

  • if you are now taken a prescription Monoaminoxidase 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

SPL UNCLASSIFIED SECTION

Do not take this product: for persistent 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.

Do not give this product if you have

SPL UNCLASSIFIED SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • if you are taking the blood thinning drug warfarin.

Stop using this product and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • symptoms do not improve within 7 days or are accompanied by fever.
  • pain or fever persists or gets worse. These could be signs of a serious condition

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not take more than 6 doses in any 24 hours period.

AgeDose
adults and children 12 years of age and over1 tablets every 4 hours.
children 6 to 12 years of age1/2 tablet every 4 hours.
children under 6 years of ageConsult a doctor.

Other information

STORAGE AND HANDLING SECTION

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

Tamper evident

SPL UNCLASSIFIED SECTION

Do not use if there is evidence of tampering.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dicalcium phosphate, magnesium stearate, maltodextrin, mirocrystalline cellulose, povidone, silicon dioxide, stearic acid, talc.

Questions or comments?

OTC - QUESTIONS SECTION

Calle de Diego #488
San Juan P.R. 00924

Phone: 787-767-3246
For more information visit
www.domelpharma.com

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53809-250-01

DOMETUSS-G

DEXTROMETHORPHAN HBr/
PHENYLEPHRINE HCl / GUAIFENESIN

  • Cough Suppressant
  • Nasal Decongestant
  • Expectorant

100 TABLETS

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2572023dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG Oral TabletPSN2
2572023dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD2

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53809-250-01DOMETUSS-G100 in 1 BOTTLETABLET1002
53809-250-04DOMETUSS-G4 in 1 BOTTLETABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53809-250DOMETUSS-G (GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [DOMEL]2Legacy NDC, 2 package rows20241208_19e06e4d-9efb-4059-a33d-4a89c3a2534c.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
53809-25053809-250-01, 53809-250-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT

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
7a021d0d-cf11-4daf-b6f6-a8b386a45e7719e06e4d-9efb-4059-a33d-4a89c3a2534c2024-12-06WarningsExact identifier
spl id: 7a021d0d-cf11-4daf-b6f6-a8b386a45e77
spl set id: 19e06e4d-9efb-4059-a33d-4a89c3a2534c

Reported adverse events (FAERS/openFDA)#

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