Dometuss - DailyMed Details

Dometuss

SPL v4

SPL

SPL Set ID 3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe

Route

ORAL

Published

Effective Date 2025-09-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (2 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Methylparaben Propylparaben Propylene Glycol Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-06

Description

Drug Facts:

Medication Information

Description

Drug Facts:

Use

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.

Section 42229-5

Drug Facts:

Section 50565-1

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

Section 50566-9

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.

Section 50567-7

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.

Section 53414-9

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

Section 55105-1

Active Ingredients (in each 5ml-teaspoonful)	Purpose
Chlorpheniramine Maleate 2mg	Antihistamine
Dextromethorphan HBr 10mg	Cough Suppresant
Phenylephrine HCl 5mg	Nasal Decongestant

Do Not Use

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.

Directions

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.

Other Information

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

Inactive Ingredients

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

Questions Or Comments?

Please call (787) 767-3246.

Tamper Evident Disclosure

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

Ask 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.

Principal Display Panel 118 Ml Bottle Label

NDC 53809-222-04

DOMETUSS

Antihistamine/Cough Suppressant/

Nasal Decongestant

Sugar, Alcohol, And Dye

Free

Grape Flavor

4 fl. oz (118 ml)

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Use

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.

Section 42229-5 (42229-5)

Drug Facts:

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active Ingredients (in each 5ml-teaspoonful)	Purpose
Chlorpheniramine Maleate 2mg	Antihistamine
Dextromethorphan HBr 10mg	Cough Suppresant
Phenylephrine HCl 5mg	Nasal Decongestant

Do Not Use (DO NOT USE)

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.

Directions

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.

Other Information

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Please call (787) 767-3246.

Tamper Evident Disclosure (Tamper-Evident Disclosure)

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

Ask A Doctor Before Use If You Have (ASK 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.

Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

NDC 53809-222-04

DOMETUSS

Antihistamine/Cough Suppressant/

Nasal Decongestant

Sugar, Alcohol, And Dye

Free

Grape Flavor

4 fl. oz (118 ml)

Ask A Doctor Or Pharmacist Before Use If You Are (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)

taking sedatives or tranquilizers.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "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.", "42229-5": "Drug Facts:", "50565-1": "KEEP OUT OF REACH OF CHILDREN . In case of accidental overdose, get medical help or contact a poison control Center right away.", "50566-9": "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.", "50567-7": "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.", "53414-9": "IF PREGNANT OR BREAST FEEDING ask a health professional before use.", "55105-1": "Active Ingredients (in each 5ml-teaspoonful) Purpose Chlorpheniramine Maleate 2mg Antihistamine Dextromethorphan HBr 10mg Cough Suppresant Phenylephrine HCl 5mg Nasal Decongestant", "DO NOT USE": "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.", "Directions": "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.", "Other Information": "store at room temperature between 15°-30°C (59°-86°F).", "Inactive ingredients": "Citric acid, flavor, methylparaben, propylparaben, propylene glycol, purified water, sodium citrate and sucralose.", "Questions or comments?": "Please call (787) 767-3246.", "Tamper-Evident Disclosure": "Do not use this product if aluminum foil over bottle opening is torn, broken or missing.", "ASK 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.", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label": "NDC 53809-222-04 DOMETUSS Antihistamine/Cough Suppressant/ Nasal Decongestant Sugar, Alcohol, And Dye Free Grape Flavor 4 fl. oz (118 ml)", "ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE": "taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.570580 · Updated: 2026-03-14T23:10:21.394156