FDA.reportPublic FDA data

DOMETUSS-DA

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-DA
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporarily relieves runny nose and sneezing itching of the nose or throat and itchy watery eyes due to hay fever or other respiratory allergies (allergic rhinitis) temporarily relieves nasal congestion due to common cold temporarily restores freer breathing through the nose

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

Chlorpheniramine Maleate 1 mg

Phenylphrine HCL 2.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal Decongestant

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

  • Temporarily relieves runny nose and sneezing
  • itching of the nose or throat and itchy
  • watery eyes due to hay fever or other respiratory allergies (allergic rhinitis)
  • temporarily relieves nasal congestion due to common cold
  • temporarily restores freer breathing through the nose

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-DA product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53809-206-04

DOMETUSS-DA

NASAL DECONGESTANT & ANTIHISTAMINIC

  • Itchy, Waterl Eyes
  • Runny Nose
  • Stuffy Nose
  • Sneezing

bubble gum flavor

4 fl. oz. (118 mL)

Rev: 05/13

Lot #

Exp:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

Domel Dometuss 206Domel Dometuss 206

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1429345chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG in 5 mL Oral SolutionPSN4
1429345chlorpheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD4
1429345chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
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
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53809-206-042025-05-20C16284748780-12cef2736-5f47-d83d-e063-dadaa90ab31fDOMETUSS-DA
53809-206-042025-01-30C16284748780-12cef2736-5f47-d83d-e063-dadaa90ab31fDOMETUSS-DA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53809-206-04DOMETUSS-DA118 mL in 1 BOTTLELIQUID1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53809-206DOMETUSS-DA (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DOMEL LABORATORIES]4Legacy NDC, 1 package rows20250522_b5def3fb-90b9-4b7e-bb22-745804b0566a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53809-206-04ML - Milliliter53809-206c35cdd8d-06df-46f9-9292-6619ce5dfe2912016-02-04

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
53809-20653809-206-04

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
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
D&C RED NO. 339DBA0SBB0LIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML · Source PDF

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
7ed906cf-a0da-450e-a245-2bb689dc997bb5def3fb-90b9-4b7e-bb22-745804b0566a2024-12-05WarningsExact identifier
spl id: 7ed906cf-a0da-450e-a245-2bb689dc997b
spl set id: b5def3fb-90b9-4b7e-bb22-745804b0566a

Reported adverse events (FAERS/openFDA)#

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