Dometuss

Manufacturer
Dextrum Laboratories, Inc
Effective date
2025-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:06

Label at a glance#

ProductDometuss
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure15 sections

Dosage and administration

Directions: Do not exceed more than 6 doses in a 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

Other information: store at room temperature between 15-30 C( 59-86 F)

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

purposepurposeAnthistamine

cough suppresant

nasal descongestant.

Use

For temporary relief of runny nose, sneezing, itching of the nose orthroat and itchywatery eyes due to hay fever.

Temporary relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

temporary restores freer breathing through the nose.

OTC - ACTIVE INGREDIENT SECTION

activeactiveActive Ingredients ( in each 5ml-teaspoonful)

Chlorpheniramine Maleate 2mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

WARNINGS SECTION

WarningWarningWarnings: Do not use

  • To sedate a child or to make a child sleepy.
  • If you are now taking a prescription monoamine oxidose inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditiosn 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, asl a doctor or pharmacist before taking this product.

OTC - ASK DOCTOR SECTION

Ask a doctorAsk a doctorAsk a Doctor Before use if you have

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.

OTC - WHEN USING SECTION

When Using SectionWhen 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 carefulwhen driving a motor vehicleor operating machinery

excitability may occur, especially with children

OTC - STOP USE SECTION

Stop use sectionStop 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 fiver, rash or persistent headaches. These could be signs of a serious condition.

If pregnant

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnantIf pregnant

If pregnant or breast feeding ask a health professional before use.

Keep Out

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep outKeep out

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

DirectionsDirections

Directions:

Do not exceed more than 6 doses in a 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.

Other information

STORAGE AND HANDLING SECTION

Other InformationOther Information

Other information: store at room temperature between 15-30 C( 59-86 F)

Tamper-Evident

OTHER SAFETY INFORMATION

TamperTamper

Tamper-Evident Disclosure: Do not use this product if aluminum foil over bottle opening is torn, broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

Inactive ingredients:

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

Question

OTC - QUESTIONS SECTION

questionquestion

Questions or Comments? Please call (787)767-3246.

Indication and usage section

INDICATIONS & USAGE SECTION

indication and userindication and user:

Indication and usage section:

adults and children 12 year of age and over--- 2 teaspoonful (10ml) every 4 hours

Childrens 6 to under 12 years of age------ i teaspoonful (5ml) every 4 hours

Childrens under 6 years of age------ask a doctor

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DometussDometussDometuss

Antihistamine/Cough Suppressant/Nasal Decongestant

Sugar, Alcohol, And Dye

Free

Grape Flavor

4 fl oz ( 118 ml)

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 SolutionPSN1
1363752chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD1
1363752chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY1

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
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e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-002-04Dometuss118 mL in 1 BOTTLE, PLASTICLIQUID1181

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
65852-00265852-002-04

Ingredients#

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

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

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 HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc3fcace53-a81f-e774-e063-6294a90a32fa2025-09-27WarningsExact identifier
ndc (package): 65852-002-04
ndc (product): 65852-002
ndc11 (package): 65852000204
spl id: 3fcace53-a820-e774-e063-6294a90a32fa
spl set id: 3fcace53-a81f-e774-e063-6294a90a32fa

Reported adverse events (FAERS/openFDA)#

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