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Maximum Strength Mucus Relief DM

Guaifenesin and Dextromethorphan HBr · 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
Maximum Strength Mucus Relief DM
Generic name
Guaifenesin and Dextromethorphan HBr
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
WALGREEN CO.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
5
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 60 mg/1 1094538 View
Guaifenesin 1200 mg/1 359601 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
7

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
206941
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 17, 2017
Sponsor
AUROBINDO PHARMA
Products on application
2
Submissions recorded
1
Products approved under application 206941.
Product Trade name Form Strength Ingredient Status TE Flags
206941-001 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN Over-the-counter —
206941-002 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 206941.
Type No. Action Status Date Review
Original application 1 Approved March 17, 2017 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260828). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260828 HUMAN OTC DRUG · 20240203

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

Purpose

openFDA Drug Labeling

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: 1extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours children under 12 years of age: do not use

Warnings

openFDA Drug Labeling

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

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

openFDA Drug Labeling

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 Hydrobromide USP 60 mg Guaifenesin USP 1200 mg

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
0363-0510-65 0363-0510 WALGREEN CO. 2 BLISTER PACK in 1 CARTON (0363-0510-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
0363-0510-70 0363-0510 WALGREEN CO. 4 BLISTER PACK in 1 CARTON (0363-0510-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
0363-0510-99 0363-0510 WALGREEN CO. 6 BLISTER PACK in 1 CARTON (0363-0510-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
49035-956-61 49035-956 Wal-Mart Stores, Inc. 1 BOTTLE in 1 CARTON (49035-956-61) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
49035-956-65 49035-956 Wal-Mart Stores, Inc. 1 BOTTLE in 1 CARTON (49035-956-65) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
0363-0510 0363-0510 WALGREEN CO. — March 17, 2017
49035-956 49035-956 Wal-Mart Stores, Inc. — March 17, 2017

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.