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Dextromethorphan Hbr and Guaifenesin Oral Solution

OTC Oral RxCUI 996520
Contents

Overview

Active ingredient
Guaifenesin, Dextromethorphan Hydrobromide
Established class
Expectorant
Physiologic effect
Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
Route
Oral
Label date
2025-01-30

Indications and usage

USES temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Purpose

Dextromethorphan HBr and Guaifenesin Oral Solution 5 and 10 mL Disclaimer: Most OTC drugs are not reviewed and approved by the FDA, however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. DM Guaifenesin Non-Narcotic, Sugar, Dye and Alcohol Free Cough Suppressant/Expectorant

Dosage and administration

DIRECTIONS DIRECTIONS Follow dosage table below or use as directed by a physician Do not take more than 6 doses in any 24-hour period Age Dose adults and children 12 years and over 10mL (2 teaspoonful) every 4 hours children 6 to under 12 years of age 5mL (1 teaspoonful) every 4 hours children 2 to under 6 years of age 2.5mL (1/2 teaspoonful) every 4 hours children under 2 years consult a doctor

Warnings

Do not use 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 Ask a doctor before use if you have Cough that occurs with too much phlegm (mucus) Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask a doctor if

and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. you are hypersensitive to any of the ingredients.

Pregnancy or breast-feeding

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

Description

Each 5 mL (1 teaspoonful) contains: Dextromethorphan Hydrobromide 10 mg Guaifenesin 100 mg Each 10 mL (2 teaspoonfuls) contains: Dextromethorphan Hydrobromide 20 mg Guaifenesin 200 mg

Inactive ingredients

s Inactive Ingredients: citric acid, grape flavor, methylparaben, monoammonium glycrrhizate, potassium citrate, propylene glycol, propylparaban,purified water, sorbitol, sucralose.

Storage and handling

STORAGE Store at controlled temperature 15°C to 30°C (59°F to 86°F) [See USP]. Protect from light.

Keep out of reach of children

of children. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA)