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Mucus Relief DM

Guaifenesin, Dextromethorphan HBr · Tablet

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
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Care One (Retail Business Services, LLC.)
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
19
Packages
30
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 20 mg/1 1094538 View
Dextromethorphan Hydrobromide 30 mg/1 1094538 View
Dextromethorphan Hydrobromide 60 mg/1 1094538 View
Guaifenesin 1200 mg/1 359601 View
Guaifenesin 400 mg/1 359601 View
Guaifenesin 600 mg/1 359601 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
49

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 20251226). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251226 HUMAN OTC DRUG · 20251111 HUMAN OTC DRUG · 20250820 HUMAN OTC DRUG · 20250601

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 o cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants o the intensity of coughing o the impulse to cough to help you get to sleep

Purpose Dextromethorphan HBr 20 mg ......................................... Cough suppressant Guaifenesin 400mg ........................................................................ Expectorant

Dosage and Administration

openFDA Drug Labeling

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

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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough accompanied by too much phlegm (mucus) Ask a doctor or pharmacist before use if taking sedatives or tranquilizers 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 Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 excessive phlegm (mucus)

Stop use and ask a doctor if symptoms are accompanied by fever, rash, or persistent headache cough persists for more than one week or tends to recur These could be signs of a serious condition.

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 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
80513-407-09 80513-407 Advanced Rx LLC 90 TABLET in 1 BOTTLE (80513-407-09) January 1, 2025
69168-432-06 69168-432 Allegiant Health 120 TABLET in 1 BOTTLE (69168-432-06) November 6, 2023
69168-432-07 69168-432 Allegiant Health 1 BOTTLE in 1 CARTON (69168-432-07) / 10 TABLET in 1 BOTTLE May 18, 2022
69168-432-26 69168-432 Allegiant Health 1 BOTTLE in 1 CARTON (69168-432-26) / 20 TABLET in 1 BOTTLE May 18, 2022
69168-432-30 69168-432 Allegiant Health 30 TABLET in 1 BOTTLE (69168-432-30) November 6, 2023
69168-432-50 69168-432 Allegiant Health 50 TABLET in 1 BOTTLE (69168-432-50) June 8, 2022
69168-432-98 69168-432 Allegiant Health 200 TABLET in 1 BOTTLE (69168-432-98) May 18, 2022
63941-733-20 63941-733 Best Choice (Valu Merchandisers Company) 20 BLISTER PACK in 1 CARTON (63941-733-20) / 1 TABLET in 1 BLISTER PACK January 14, 2022
63941-734-14 63941-734 Best Choice (Valu Merchandisers Company) 14 BLISTER PACK in 1 CARTON (63941-734-14) / 1 TABLET in 1 BLISTER PACK January 14, 2022
37835-403-40 37835-403 Bi-Mart 40 TABLET in 1 BOTTLE (37835-403-40) June 1, 2025
72476-733-20 72476-733 Care One (Retail Business Services, LLC.) 20 BLISTER PACK in 1 CARTON (72476-733-20) / 1 TABLET in 1 BLISTER PACK July 23, 2021
72476-734-14 72476-734 Care One (Retail Business Services, LLC.) 14 BLISTER PACK in 1 CARTON (72476-734-14) / 1 TABLET in 1 BLISTER PACK November 29, 2019
68016-674-14 68016-674 Chain Drug Consortium, LLC 14 BLISTER PACK in 1 CARTON (68016-674-14) / 1 TABLET in 1 BLISTER PACK November 29, 2019
68016-674-28 68016-674 Chain Drug Consortium, LLC 28 BLISTER PACK in 1 CARTON (68016-674-28) / 1 TABLET in 1 BLISTER PACK November 29, 2019
55910-733-06 55910-733 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 6 BLISTER PACK in 1 CARTON (55910-733-06) / 1 TABLET in 1 BLISTER PACK March 31, 2019
55910-733-20 55910-733 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 20 BLISTER PACK in 1 CARTON (55910-733-20) / 1 TABLET in 1 BLISTER PACK March 31, 2019
50804-432-30 50804-432 Good Sense 1 BOTTLE in 1 CARTON (50804-432-30) / 30 TABLET in 1 BOTTLE May 18, 2022
41226-280-03 41226-280 KROGER COMPANY 30 TABLET in 1 BOTTLE (41226-280-03) June 3, 2019
84324-035-01 84324-035 NUVICARE LLC 100 TABLET in 1 BOTTLE (84324-035-01) February 2, 2026
59726-733-06 59726-733 P & L Development, LLC 6 BLISTER PACK in 1 CARTON (59726-733-06) / 1 TABLET in 1 BLISTER PACK December 31, 2018
59726-733-20 59726-733 P & L Development, LLC 20 BLISTER PACK in 1 CARTON (59726-733-20) / 1 TABLET in 1 BLISTER PACK December 31, 2018
59726-733-40 59726-733 P & L Development, LLC 40 BLISTER PACK in 1 CARTON (59726-733-40) / 1 TABLET in 1 BLISTER PACK December 31, 2018
72090-027-01 72090-027 Pioneer Life Sciences, LLC 150 TABLET in 1 BOTTLE (72090-027-01) October 4, 2024
11822-0733-2 11822-0733 Rite Aid Corporation 20 BLISTER PACK in 1 CARTON (11822-0733-2) / 1 TABLET in 1 BLISTER PACK February 28, 2019
11822-0733-4 11822-0733 Rite Aid Corporation 40 BLISTER PACK in 1 CARTON (11822-0733-4) / 1 TABLET in 1 BLISTER PACK February 28, 2019
11822-0733-6 11822-0733 Rite Aid Corporation 68 BLISTER PACK in 1 CARTON (11822-0733-6) / 1 TABLET in 1 BLISTER PACK February 28, 2019
11822-7340-4 11822-7340 Rite Aid Corporation 42 BLISTER PACK in 1 CARTON (11822-7340-4) / 1 TABLET in 1 BLISTER PACK May 31, 2019
76162-008-01 76162-008 TopCo Associates, LLC 100 TABLET in 1 BOTTLE (76162-008-01) October 31, 2022
67091-344-20 67091-344 WinCo Foods, LLC 20 BLISTER PACK in 1 CARTON (67091-344-20) / 1 TABLET in 1 BLISTER PACK September 1, 2019
67091-345-14 67091-345 WinCo Foods, LLC 14 BLISTER PACK in 1 CARTON (67091-345-14) / 1 TABLET in 1 BLISTER PACK September 1, 2019
80513-407 80513-407 Advanced Rx LLC — January 1, 2025
69168-432 69168-432 Allegiant Health — May 18, 2022
63941-733 63941-733 Best Choice (Valu Merchandisers Company) — January 14, 2022
63941-734 63941-734 Best Choice (Valu Merchandisers Company) — January 14, 2022
37835-403 37835-403 Bi-Mart — June 1, 2025
72476-733 72476-733 Care One (Retail Business Services, LLC.) — July 23, 2021
72476-734 72476-734 Care One (Retail Business Services, LLC.) — November 29, 2019
68016-674 68016-674 Chain Drug Consortium, LLC — November 29, 2019
55910-733 55910-733 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) — March 31, 2019
50804-432 50804-432 Good Sense — May 18, 2022
41226-280 41226-280 KROGER COMPANY — June 3, 2019
84324-035 84324-035 NUVICARE LLC — February 2, 2026
59726-733 59726-733 P & L Development, LLC — December 31, 2018
72090-027 72090-027 Pioneer Life Sciences, LLC — October 4, 2024
11822-0733 11822-0733 Rite Aid Corporation — February 28, 2019
11822-7340 11822-7340 Rite Aid Corporation — May 31, 2019
76162-008 76162-008 TopCo Associates, LLC — October 31, 2022
67091-344 67091-344 WinCo Foods, LLC — September 1, 2019
67091-345 67091-345 WinCo Foods, LLC — September 1, 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 · 11 sections on this page.