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Mucus Relief DM

Guaifenesin, 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
Mucus Relief DM
Generic name
Guaifenesin, Dextromethorphan HBr
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
H E B
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
22
Packages
33
Data completeness
82% 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
55

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
209692
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 1, 2018
Sponsor
AMNEAL PHARMS
Products on application
2
Submissions recorded
1
Products approved under application 209692.
Product Trade name Form Strength Ingredient Status TE Flags
209692-001 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN Over-the-counter —
209692-002 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 209692.
Type No. Action Status Date Review
Original application 1 Approved November 1, 2018 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 · 20231201

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 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
60000-057-65 60000-057 Ahold U.S.A., Inc 1 BOTTLE in 1 CARTON (60000-057-65) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
60000-058-67 60000-058 Ahold U.S.A., Inc 1 BOTTLE in 1 CARTON (60000-058-67) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
21130-997-67 21130-997 Better Living Brands LLC 2 BLISTER PACK in 1 CARTON (21130-997-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
51316-671-55 51316-671 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-671-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE December 17, 2025
51316-671-66 51316-671 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-671-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE January 12, 2026
51316-858-01 51316-858 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-858-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE June 1, 2026
51316-858-78 51316-858 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-858-78) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE July 14, 2025
81522-734-14 81522-734 FSA Store Inc. (Caring Mills) 14 BLISTER PACK in 1 CARTON (81522-734-14) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK December 31, 2023
55319-734-07 55319-734 Family Dollar (FAMILY WELLNESS) 7 BLISTER PACK in 1 CARTON (55319-734-07) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 1, 2023
55319-741-14 55319-741 Family Dollar (FAMILY WELLNESS) 14 BLISTER PACK in 1 CARTON (55319-741-14) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK April 1, 2025
37808-730-42 37808-730 H E B 1 BOTTLE, PLASTIC in 1 BOX (37808-730-42) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC March 15, 2023
37808-733-20 37808-733 H E B 1 BOTTLE, PLASTIC in 1 BOX (37808-733-20) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC February 28, 2023
37808-733-40 37808-733 H E B 1 BOTTLE, PLASTIC in 1 BOX (37808-733-40) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC February 28, 2023
37808-834-14 37808-834 H E B 1 BOTTLE, PLASTIC in 1 BOX (37808-834-14) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC March 15, 2023
72036-012-20 72036-012 Harris Teeter 2 BLISTER PACK in 1 CARTON (72036-012-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 16, 2024
72036-980-65 72036-980 Harris Teeter 2 BLISTER PACK in 1 CARTON (72036-980-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
72036-980-70 72036-980 Harris Teeter 4 BLISTER PACK in 1 CARTON (72036-980-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
41250-436-01 41250-436 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-436-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE June 2, 2020
41250-436-49 41250-436 Meijer Distribution Inc 1 BOTTLE in 1 CARTON (41250-436-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE June 2, 2020
83324-137-14 83324-137 QUALITY CHOICE (Chain Drug Marketing Association) 14 BLISTER PACK in 1 CARTON (83324-137-14) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 31, 2024
11822-2219-0 11822-2219 Rite Aid Corporation 1 BOTTLE in 1 CARTON (11822-2219-0) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE March 15, 2023
11822-2219-1 11822-2219 Rite Aid Corporation 1 BOTTLE in 1 CARTON (11822-2219-1) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE March 16, 2023
70677-1049-1 70677-1049 Strategic Sourcing Services LLC 14 BLISTER PACK in 1 CARTON (70677-1049-1) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 1, 2023
70677-1050-1 70677-1050 Strategic Sourcing Services LLC 20 BLISTER PACK in 1 CARTON (70677-1050-1) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 31, 2023
0363-0474-01 0363-0474 WALGREEN CO. 4 BLISTER PACK in 1 CARTON (0363-0474-01) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
0363-0474-67 0363-0474 WALGREEN CO. 2 BLISTER PACK in 1 CARTON (0363-0474-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
49035-960-12 49035-960 Wal-Mart Stores, Inc. 1 BOTTLE in 1 CARTON (49035-960-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
49035-960-73 49035-960 Wal-Mart Stores, Inc. 1 BOTTLE in 1 CARTON (49035-960-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
0363-3219-01 0363-3219 Walgreen Company 1 BOTTLE in 1 CARTON (0363-3219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE February 9, 2024
0363-3219-49 0363-3219 Walgreen Company 1 BOTTLE in 1 CARTON (0363-3219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE February 5, 2024
0363-6812-30 0363-6812 Walgreen Company 1 BOTTLE in 1 CARTON (0363-6812-30) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE January 7, 2019
0363-6812-55 0363-6812 Walgreen Company 1 BOTTLE in 1 CARTON (0363-6812-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE December 21, 2018
0363-6812-66 0363-6812 Walgreen Company 1 BOTTLE in 1 CARTON (0363-6812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE January 7, 2019
60000-057 60000-057 Ahold U.S.A., Inc — March 17, 2017
60000-058 60000-058 Ahold U.S.A., Inc — March 17, 2017
21130-997 21130-997 Better Living Brands LLC — March 17, 2017
51316-671 51316-671 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED — December 17, 2025
51316-858 51316-858 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED — July 14, 2025
81522-734 81522-734 FSA Store Inc. (Caring Mills) — December 31, 2023
55319-734 55319-734 Family Dollar (FAMILY WELLNESS) — July 1, 2023
55319-741 55319-741 Family Dollar (FAMILY WELLNESS) — April 1, 2025
37808-730 37808-730 H E B — March 15, 2023
37808-733 37808-733 H E B — February 28, 2023
37808-834 37808-834 H E B — March 15, 2023
72036-012 72036-012 Harris Teeter — August 16, 2024
72036-980 72036-980 Harris Teeter — March 17, 2017
41250-436 41250-436 Meijer Distribution Inc — June 2, 2020
83324-137 83324-137 QUALITY CHOICE (Chain Drug Marketing Association) — July 31, 2024
11822-2219 11822-2219 Rite Aid Corporation — March 15, 2023
70677-1049 70677-1049 Strategic Sourcing Services LLC — March 1, 2023
70677-1050 70677-1050 Strategic Sourcing Services LLC — March 31, 2023
0363-0474 0363-0474 WALGREEN CO. — March 17, 2017
49035-960 49035-960 Wal-Mart Stores, Inc. — March 17, 2017
0363-3219 0363-3219 Walgreen Company — February 5, 2024
0363-6812 0363-6812 Walgreen Company — December 21, 2018

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 · 11 sections on this page.