ROBAFEN DM

ROBAFEN DM is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN manufactured by A-S Medication Solutions administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231022.

Generic: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Manufacturer: A-S Medication Solutions

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 50090-6747

Application: M102

Effective: 20231022

Active Ingredients: Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

Indications & 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 drain bronchial tubes

Dosage & Administration

Directions • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use

Contraindications

Not available.

Warnings

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 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 cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. 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 (1-800-222-1222).

Adverse Reactions

Not available.

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