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Good Sense Mucus DM

dextromethorphan HBr, guaifenesin · Tablet, Extended Release

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Good Sense Mucus DM
Generic name
dextromethorphan HBr, guaifenesin
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
L Perrigo Company
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
10
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Dextromethorphan Hydrobromide 30 mg/1 1094538 View
Dextromethorphan Hydrobromide 60 mg/1 1094538 View
Guaifenesin 1200 mg/1 359601 View
Guaifenesin 600 mg/1 359601 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
14

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Decreased Respiratory Secretion Viscosity [PE] PE All 52 members
Expectorant [EPC] EPC All 48 members
Increased Respiratory Secretions [PE] PE All 48 members
Sigma-1 Agonist [EPC] EPC All 44 members
Sigma-1 Receptor Agonists [MoA] MoA All 44 members
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] EPC All 44 members
Uncompetitive NMDA Receptor Antagonists [MoA] MoA All 44 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207602
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 5, 2018
Sponsor
PERRIGO R AND D
Products on application
2
Submissions recorded
1
Products approved under application 207602.
Product Trade name Form Strength Ingredient Status TE Flags
207602-001 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN Over-the-counter —
207602-002 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 207602.
Type No. Action Status Date Review
Original application 1 Approved March 5, 2018 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260713). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260713 HUMAN OTC DRUG · 20250820 HUMAN OTC DRUG · 20240926

Indications and Usage

openFDA Drug Labeling

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep

Purposes Cough suppressant Expectorant

Dosage and Administration

openFDA Drug Labeling

Directions • do not crush, chew, or break extended-release tablet • take with a full glass of water • this product can be administered without regard for timing of meals • adults and children 12 years and older: 1 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours • children under 12 years of age: do not use

Warnings Do not use • for children under 12 years of age • 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 • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) When using this product • do not use more than directed Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. 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).

Do not use • for children under 12 years of age • 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

openFDA Drug Labeling

Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 1200 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-7258 NDC: 50090-7258-0 14 TABLET, EXTENDED RELEASE in a BOTTLE / 1 in a CARTON

Adverse event reports

Source: openFDA FAERS
202,963
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: GUAIFENESIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50090-7258-0 50090-7258 A-S Medication Solutions 1 BOTTLE in 1 CARTON (50090-7258-0) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE September 24, 2024
0113-0812-03 0113-0812 L Perrigo Company 7 BLISTER PACK in 1 CARTON (0113-0812-03) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK September 9, 2021
0113-0812-66 0113-0812 L Perrigo Company 1 BOTTLE in 1 CARTON (0113-0812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE June 21, 2018
0113-2219-01 0113-2219 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-2219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE July 10, 2019
0113-2219-49 0113-2219 L. Perrigo Company 1 BOTTLE in 1 CARTON (0113-2219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE June 19, 2023
85766-172-20 85766-172 Sportpharm LLC 1 BOTTLE in 1 CARTON (85766-172-20) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE February 24, 2026
85766-172-30 85766-172 Sportpharm LLC 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (85766-172-30) February 24, 2026
85766-172-40 85766-172 Sportpharm LLC 40 TABLET, EXTENDED RELEASE in 1 BOTTLE (85766-172-40) February 24, 2026
85766-172-60 85766-172 Sportpharm LLC 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (85766-172-60) February 24, 2026
85766-172-90 85766-172 Sportpharm LLC 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (85766-172-90) February 24, 2026
50090-7258 50090-7258 A-S Medication Solutions — June 21, 2018
0113-0812 0113-0812 L Perrigo Company — June 21, 2018
0113-2219 0113-2219 L. Perrigo Company — July 10, 2019
85766-172 85766-172 Sportpharm LLC — July 10, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.