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Dextromethorphan Hydrobromide, Guaifenesin and Pseudoephedrine Hydrochloride

OTC Oral RxCUI 1426660
Contents

Overview

Active ingredient
Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride
Established class
Expectorant
Physiologic effect
Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
Route
Oral
Label date
2025-12-03

Indications and usage

Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive nasal congestion reduces swelling of nasal passages

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Dosage and administration

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age: Consult a doctor.

Warnings

Do not exceed recommended dosage. 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. Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlargement of the prostate gland 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 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.

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.

Ask a doctor before use if

Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlargement of the prostate gland

Stop use and ask a doctor if

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 fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur

Pregnancy or breast-feeding

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

Active ingredient (label)

s (in each tablet) Dextromethorphan HBr 15mg

s (in each tablet) Guaifenesin 400mg

s (in each tablet) Pseudoephedrine HCl 60mg

Inactive ingredients

s FD&C Blue #1, FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate.

Keep out of reach of children

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