Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion

DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN ORAL HUMAN OTC DRUG

Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion is an FDA drug label for the active ingredient DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN manufactured by AMERISOURCE BERGEN 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 20260713.

Generic name
DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN
Manufacturer
AMERISOURCE BERGEN
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
46122-783
Application
M012
Label effective
20260713

About this product

Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN. It is labelled by AMERISOURCE BERGEN taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 46122-783, application M012, label effective 20260713. It is one of 10 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritation, cold helps, loosen phlegm, secretions drain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each 20 ml) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg Purposes Cough suppressant Expectorant

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

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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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 at 1-800-222-1222.

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How products containing DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN compare

FDA lists 10 drug label records with DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Reckitt Benckiser LLC 5
— — AMERISOURCE BERGEN 2
— — CVS PHARMACY 1
— — CVS PHARMACY, INC 1
— — RARITAN PHARMACEUTICALS INC 1

Recall and safety notices

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-1066-2013 Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22 AmeriSource Bergen Class II Terminated 20131009
D-1065-2013 Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22 AmeriSource Bergen Class II Terminated 20131009

Frequently asked questions

What is Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion used for?
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

Who makes Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion?
AMERISOURCE BERGEN is the labeler of record for Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion. 10 FDA label records share the active ingredient DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN?
Yes. 10 FDA drug label records list DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.