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Mucus Relief DM Extended Release Caplets

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 Extended Release Caplets
Generic name
Guaifenesin, Dextromethorphan HBr
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Walgreens
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
6
Packages
10
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
Route of administration
Oral
Presentations
16

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 20250828). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250828 HUMAN OTC DRUG · 20231122 HUMAN OTC DRUG · 20230503

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 Cough Suppressant 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 for children under12 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 under12 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: 50090-6020 NDC: 50090-6020-0 1 TABLET in a BLISTER PACK / 14 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
50090-6020-0 50090-6020 A-S Medication Solutions 14 BLISTER PACK in 1 CARTON (50090-6020-0) / 1 TABLET in 1 BLISTER PACK June 27, 2022
70000-0464-1 70000-0464 Cardinal Health (Leader) 70000 28 BLISTER PACK in 1 CARTON (70000-0464-1) / 1 TABLET in 1 BLISTER PACK December 31, 2018
70000-0464-2 70000-0464 Cardinal Health (Leader) 70000 14 BLISTER PACK in 1 CARTON (70000-0464-2) / 1 TABLET in 1 BLISTER PACK December 31, 2018
49035-824-28 49035-824 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 1 BOTTLE, PLASTIC in 1 BOX (49035-824-28) / 28 TABLET in 1 BOTTLE, PLASTIC November 29, 2019
63868-870-14 63868-870 QUALITY CHOICE (Chain Drug Marketing Association) 14 BLISTER PACK in 1 CARTON (63868-870-14) / 1 TABLET in 1 BLISTER PACK December 31, 2018
0363-0437-14 0363-0437 Walgreens 14 BLISTER PACK in 1 CARTON (0363-0437-14) / 1 TABLET in 1 BLISTER PACK January 1, 2019
0363-0437-28 0363-0437 Walgreens 28 BLISTER PACK in 1 CARTON (0363-0437-28) / 1 TABLET in 1 BLISTER PACK January 1, 2019
0363-0437-42 0363-0437 Walgreens 42 BLISTER PACK in 1 CARTON (0363-0437-42) / 1 TABLET in 1 BLISTER PACK January 1, 2019
0363-0733-20 0363-0733 Walgreens 20 BLISTER PACK in 1 CARTON (0363-0733-20) / 1 TABLET in 1 BLISTER PACK January 1, 2019
0363-0733-40 0363-0733 Walgreens 40 BLISTER PACK in 1 CARTON (0363-0733-40) / 1 TABLET in 1 BLISTER PACK January 1, 2019
50090-6020 50090-6020 A-S Medication Solutions — November 5, 2018
70000-0464 70000-0464 Cardinal Health (Leader) 70000 — December 31, 2018
49035-824 49035-824 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) — November 29, 2019
63868-870 63868-870 QUALITY CHOICE (Chain Drug Marketing Association) — December 31, 2018
0363-0437 0363-0437 Walgreens — January 1, 2019
0363-0733 0363-0733 Walgreens — January 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.