FDA.reportPublic FDA data

DOMETUSS-NR

Manufacturer
Domel Laboratories | Lex Inc
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:13

Label at a glance#

ProductDOMETUSS-NR
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever. Nasal congestion due to the common cold. coughs due to minor throat and bronchial irritation as may occur with a cold.

Dosage and administration

Do not take more than 6 tablets in 24 hours, or as directed by a doctor. Age Dose adults and children 12 years of age and over 1 tablet every 4 hours. children under 12 years of age Consult a doctor before use.

Storage and handling

store at room temperature 15°- 30°C (59° - 86°F). Tamper evident: 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
Dextromethorphan HBr20 mgCough Suppressant
Chlorpheniramine Maleate4 mgAntihistamine
Phenylephrine HCl10 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves
    • runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever.
    • Nasal congestion due to the common cold.
    • coughs due to minor throat and bronchial irritation as may occur with a cold.

Warnings

WARNINGS SECTION

  • Do not exceed recommended dosage

Do not use

OTC - DO NOT USE SECTION

  • if you are now taken 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • thyroid disease
  • trouble urinating due to enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm(mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • sedatives or tranquilizers.

Stop using this product and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headaches, these could be signs of a serious condition.

When using this product

OTC - WHEN USING SECTION

  • Excitability may occur, especially in children
  • May cause drowsiness
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • Avoid alcoholic beverages while taking this product
  • Use caution when driving motor vehicle or operating machinery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults even if you do not notice signs or symptoms.

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 tablets in 24 hours, or as directed by a doctor.

AgeDose
adults and children 12 years of age and over1 tablet every 4 hours.
children under 12 years of ageConsult a doctor before use.

Other information

STORAGE AND HANDLING SECTION

  • 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

Carbomer, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Talc.

Questions or comments?

OTC - QUESTIONS SECTION

Please call (787) 767-3246

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53809-240-01

DOMETUSS-NR

DEXTROMETHORPHAN HBr/ CHLORPHENIRAMINE
MALEATE/ PHENILEPHRINE HCl

  • Cough Suppressant
  • Antihistamine
  • Nasal decongestant

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
2167752chlorpheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Oral TabletPSN2
2167752chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD2
2167752chlorpheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53809-240-01DOMETUSS-NR100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53809-240DOMETUSS-NR (DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [DOMEL LABORATORIES]2Legacy NDC, 1 package rows20241208_ef8abf4f-ce65-45c9-9df2-23e673c13756.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53809-24053809-240-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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
6c3654f8-5829-4200-921b-e8e058c0c7b0ef8abf4f-ce65-45c9-9df2-23e673c137562024-12-06WarningsExact identifier
spl id: 6c3654f8-5829-4200-921b-e8e058c0c7b0
spl set id: ef8abf4f-ce65-45c9-9df2-23e673c13756

Reported adverse events (FAERS/openFDA)#

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