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Dextromethorphan Hbr, Phenylephrine Hcl

OTC Oral RxCUI 1535366
Contents

Overview

Active ingredient
Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Route
Oral
Label date
2023-10-10

Indications and usage

Uses temporarily relieves: nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold

Purpose

s Cough suppressant Nasal decongestant

Dosage and administration

Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = milliliter shake well before using age dose children 6 to under 12 years of age 10 mL every 4 hours children 4 to under 6 years of age 5 mL every 4 hours children under 4 years of age do not use

Warnings

Do not use in a child under 4 years of age in a child who is 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma When using this product, do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Do not use

in a child under 4 years of age in a child who is 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if

Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma

When using this product

this product, do not exceed recommended dosage.

Stop use and ask a doctor if

and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

Active ingredient (label)

s (in each 5 mL) Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg

Inactive ingredients

s acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium citrate

Storage and handling

Other information each 5 mL contains : sodium 2 mg store between 20-25°C (68-77°F). Do not refrigerate.

Keep out of reach of children

of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.