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mucus dm
dextromethorphan HBr, guaifenesin · 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 |
|---|---|---|---|---|---|---|---|
| 207602-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | TABLET, EXTENDED RELEASE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | Over-the-counter | — | ||
| 207602-002 | 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 | March 5, 2018 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260825). 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 extended-release tablet every 12 hours; not more than 2 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 |
|---|---|---|---|---|
| 46122-420-03 | 46122-420 | Amerisource Bergen | 4 BLISTER PACK in 1 CARTON (46122-420-03) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 9, 2018 |
| 46122-420-74 | 46122-420 | Amerisource Bergen | 2 BLISTER PACK in 1 CARTON (46122-420-74) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 7, 2017 |
| 42507-222-20 | 42507-222 | HyVee Inc | 1 BOTTLE in 1 CARTON (42507-222-20) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (42507-222-01) | February 25, 2026 |
| 42507-812-66 | 42507-812 | HyVee Inc | 1 BOTTLE in 1 CARTON (42507-812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (42507-812-14) | March 10, 2026 |
| 41250-812-55 | 41250-812 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-812-55) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 8, 2018 |
| 41250-812-66 | 41250-812 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-812-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 8, 2018 |
| 46122-420 | 46122-420 | Amerisource Bergen | — | August 7, 2017 |
| 42507-222 | 42507-222 | HyVee Inc | — | February 25, 2026 |
| 42507-812 | 42507-812 | HyVee Inc | — | March 10, 2026 |
| 41250-812 | 41250-812 | Meijer Distribution Inc | — | August 8, 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 · 10 sections on this page.