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Mucus Relief DM
Guaifenesin, Dextromethorphan HBr · Tablet, Extended Release
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | November 1, 2018 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses • 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 LabelingPurposes Cough suppressant Expectorant
Dosage and Administration
openFDA Drug LabelingDirections • 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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 LabelingStop 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 LabelingActive ingredients ( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.