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Mucus Relief DM
Guaifenesin, Dextromethorphan HBr · Tablet
Overview
Active ingredients
Source: 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 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 20251226). 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 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
openFDA Drug LabelingPurpose Dextromethorphan HBr 20 mg ......................................... Cough suppressant Guaifenesin 400mg ........................................................................ Expectorant
Dosage and Administration
openFDA Drug LabelingDirections 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
openFDA Drug LabelingWarnings 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
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 excessive phlegm (mucus)
Stop Use
openFDA Drug LabelingStop 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 LabelingActive ingredients (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 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 |
|---|---|---|---|---|
| 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
| 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.