FDA.reportPublic FDA data

DOMETUSS

Manufacturer
Domel Laboratories | Dextrum Laboratories
Effective date
2025-09-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:15:26

Label at a glance#

ProductDOMETUSS
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

Do not exceed more than 6 doses in any 24 hour period. Adults and children 12 years of age and over 2 teaspoonful ( 10 ml ) every 4 hours. Children 6 to under 12 years of age 1 teaspoonful ( 5 ml ) every 4 hours. Children under 6 years of age Ask a doctor.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts:

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each 5ml-teaspoonful)Purpose
Chlorpheniramine Maleate 2mgAntihistamine
Dextromethorphan HBr 10mgCough Suppresant
Phenylephrine HCl 5mgNasal Decongestant

Use

INDICATIONS & USAGE SECTION

  • For temporary relief of runny nose, sneezing, itching of the nose or throat and itchy watery eyes due to hay fever.
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
  • Temporarily restores freer breathing through the nose.

WARNINGS

WARNINGS SECTION

DO NOT USE

OTC - DO NOT USE SECTION

  • To sedate a child or to make a child sleepy.
  • 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
  • thyroid disease
  • trouble urinating due to enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm(mucus)
  • a breathing problems 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

  • When using this product.
    DO NOT EXCEED RECOMMENDED DOSAGE
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may cause increased drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially with children.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF you get nervous, dizzy, or sleepless.

  • cough last more than 7 days, comes back, or is accompanied by fever, rash or persitent headaches. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

IF PREGNANT OR BREAST FEEDING ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a poison control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed more than 6 doses in any 24 hour period.

Adults and children 12 years of age and over2 teaspoonful ( 10 ml ) every 4 hours.
Children 6 to under 12 years of age1 teaspoonful ( 5 ml ) every 4 hours.
Children under 6 years of ageAsk a doctor.

Other Information

STORAGE AND HANDLING SECTION

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

Tamper-Evident Disclosure

SPL UNCLASSIFIED SECTION

Do not use this product if aluminum foil over bottle opening is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, flavor, methylparaben, propylparaben, propylene glycol, purified water, sodium citrate and sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

Please call (787) 767-3246.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53809-222-04

DOMETUSS

Antihistamine/Cough Suppressant/
Nasal Decongestant

Sugar, Alcohol, And Dye
Free
Grape Flavor

4 fl. oz (118 ml)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN4
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD4
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY4

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
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
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53809-222-04DOMETUSS118 mL in 1 BOTTLELIQUID1184

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
53809-22253809-222-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
DOMETUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDomel Laboratories3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe2025-09-16WarningsExact identifier
ndc (package): 53809-222-04
ndc (product): 53809-222
ndc11 (package): 53809022204
spl id: 897f949d-5437-4419-a6c3-206778dbf45d
spl set id: 3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe

Reported adverse events (FAERS/openFDA)#

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