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Mucus Relief DM Extended Release Caplets
Guaifenesin, Dextromethorphan HBr · Tablet
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 20250828). 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 LabelingPurpose Cough Suppressant 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 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
openFDA Drug LabelingDo 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 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 HBr 60 mg Guaifenesin 1200 mg
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Product: 50090-6020 NDC: 50090-6020-0 1 TABLET in a BLISTER PACK / 14 in a CARTON
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 |
|---|---|---|---|---|
| 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
| 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.