Duratuss Dm - DailyMed Details

Duratuss Dm

SPL v1

SPL

SPL Set ID 413a3951-d704-f14b-e063-6394a90a06dc

Route

ORAL

Published

Effective Date 2025-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dexbrompheniramine (1 mg) Dextromethorphan (10 mg) Pseudoephedrine (30 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-15

Description

(in each 5 mL teaspoonful) Dexbrompheniramine Maleate 1 mg Dextromethorphan Hydrobromide 10 mg Pseudoephedrine Hydrochloride 30 mg

Purpose

Antihistamine Antitussive Nasal Decongestant

Medication Information

Purpose

Antihistamine

Antitussive

Nasal Decongestant

Description

(in each 5 mL teaspoonful) Dexbrompheniramine Maleate 1 mg Dextromethorphan Hydrobromide 10 mg Pseudoephedrine Hydrochloride 30 mg

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

runny nose
sneezing
itching of nose or throat
itchy, watery eyes
cough due to minor throat and bronchial irritation
nasal congestion
reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Active Ing

(in each 5 mL teaspoonful)

Dexbrompheniramine Maleate 1 mg

Dextromethorphan Hydrobromide 10 mg

Pseudoephedrine Hydrochloride 30 mg

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	2 teaspoonful (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in a 24 hours
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hours
Children under 6 years of age:	Consult a doctor.

Do Not Use

this product

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.

Other Information

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients

Citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number.

Call 1-800-882-1041

Mon. - Fri. (8 a.m. to 5 p.m. CST).

Ask A Doctor Before Use

if you have

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

Principal Display Panel

NDC 50991-142 -16

Duratuss DM

LIQUID

Antihistamine • Antitussive

Nasal Decongestant

Raspberry Bubble Gum Flavor

SUGAR FREE / ALCOHOL FREE

DYE FREE / GLUTEN FREE

16 fl oz. (473 mL)

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant cap.

THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.

Distributed by: Poly Pharmaceuticals, Owens Cross Roads, AL 35763

When Using This Product

excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Or Pharmacist Before Use

if you are

taking sedatives or tranquilizers.

Structured Label Content

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

runny nose
sneezing
itching of nose or throat
itchy, watery eyes
cough due to minor throat and bronchial irritation
nasal congestion
reduces swelling of nasal passages

Purpose

Antihistamine

Antitussive

Nasal Decongestant

Warnings

Do not exceed recommended dosage.

Active Ing

(in each 5 mL teaspoonful)

Dexbrompheniramine Maleate 1 mg

Dextromethorphan Hydrobromide 10 mg

Pseudoephedrine Hydrochloride 30 mg

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	2 teaspoonful (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in a 24 hours
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hours
Children under 6 years of age:	Consult a doctor.

Do Not Use (Do not use)

this product

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.

Other Information (Other information)

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients (Inactive ingredients)

Citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number.

Call 1-800-882-1041

Mon. - Fri. (8 a.m. to 5 p.m. CST).

Ask A Doctor Before Use (Ask a doctor before use)

if you have

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50991-142 -16

When Using This Product (When using this product)

excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Or Pharmacist Before Use (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)

{"Uses": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages", "Purpose": "Antihistamine Antitussive Nasal Decongestant", "Warnings": "Do not exceed recommended dosage. ", "Active Ing": "(in each 5 mL teaspoonful) Dexbrompheniramine Maleate 1 mg Dextromethorphan Hydrobromide 10 mg Pseudoephedrine Hydrochloride 30 mg", "Directions": "Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonful (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in a 24 hours Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hours Children under 6 years of age: Consult a doctor.", "Do not use": "this product 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.", "Other information": "Store at 59° - 86°F (15° - 30°C)", "Inactive ingredients": "Citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.", "Questions? Comments?": "Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST).", "Ask a doctor before use": "if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes", "PRINCIPAL DISPLAY PANEL": "NDC 50991-142 -16 Duratuss DM LIQUID Antihistamine • Antitussive Nasal Decongestant Raspberry Bubble Gum Flavor SUGAR FREE / ALCOHOL FREE DYE FREE / GLUTEN FREE 16 fl oz. (473 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Dispense in a tight, light-resistant container with a child-resistant cap. THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER. Distributed by: Poly Pharmaceuticals, Owens Cross Roads, AL 35763", "When using this product": "excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor or pharmacist before use": "if you are taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:42.885159 · Updated: 2026-03-14T23:13:03.799451