Drugplain

Tussin DM 10 mg/5mL

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN · LIQUID · Discount Drug Mart

6 Recalls on Record
Plain English

Tussin DM is an over-the-counter liquid cough medicine that combines dextromethorphan (a cough suppressant) with guaifenesin (an expectorant) to help relieve coughs and loosen mucus. It is taken by mouth and comes in a liquid form with a strength of 10 mg/5 mL.

Key Facts

Brand Name
Tussin DM
Generic Name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
NDC Code (Product)
53943-503
Manufacturer
Discount Drug Mart
Strength
10 mg/5mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
11/19/2014

Recall History

6 Recalls on Record
Class III04/11/2014

Aaron Industries Inc

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.

TerminatedVoluntary: Firm initiated
Class III03/29/2022

AptaPharma Inc.

Incorrect/Undeclared Excipient: Product contains alcohol

TerminatedVoluntary: Firm initiated
Class II05/31/2019

Geritrex, LLC

cGMP Deviations: Products may have microbial contamination.

TerminatedVoluntary: Firm initiated
Class II06/21/2019

Pharma-Natural Inc.

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

TerminatedVoluntary: Firm initiated
Class II05/03/2023

Denison Pharmaceuticals, LLC

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

OngoingVoluntary: Firm initiated
Class II06/23/2023

Kramer Laboratories, Inc.

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective42 reports
diarrhoea38 reports
nausea33 reports
cough32 reports
dyspnoea31 reports
dizziness27 reports
fatigue27 reports
headache25 reports
pneumonia20 reports
anxiety18 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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

Frequently Asked Questions

What is Tussin DM used for?

Tussin DM is an over-the-counter liquid cough medicine that combines dextromethorphan (a cough suppressant) with guaifenesin (an expectorant) to help relieve coughs and loosen mucus. It is taken by mouth and comes in a liquid form with a strength of 10 mg/5 mL.

Is Tussin DM a controlled substance?

Tussin DM is not classified as a controlled substance by the DEA.

What is the generic name for Tussin DM?

The generic name for Tussin DM is DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN. There are 11 other brand versions of DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN.

What is the NDC code for Tussin DM 10 mg/5mL?

The NDC (National Drug Code) for Tussin DM 10 mg/5mL is 53943-503, listed by Discount Drug Mart.