■Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ■Helps make coughs more productive.
■ Adults and children 12 years and over: take 1 tablet every 4 hours as needed ■ Children 6 to under 12 years: take 1/2 tablet every 4 hours as needed ■ Children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor
| Active ingredient (per tablet) | Purpose |
| Dextromethorphan Hydrobromide 20mg | Cough Suppressant |
| Guaifenesin 400mg | Expectorant |
■Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■Helps make coughs more productive.
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 a MAOI, ask a doctor or pharmacist before using 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 that is accompanied by excessive phlegm (mucus)
Stop use and ask a doctor if
■ symptoms are accompanied by fever, rash, or persistent headache
■ cough persists for more than 1 week or tends to recur.
A persistent cough may be a sign of a serious condition.
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 immediately.
■ Adults and children 12 years and over: take 1 tablet every 4 hours as needed
■ Children 6 to under 12 years: take 1/2 tablet every 4 hours as needed
■ Children under 6 years: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
■ store at USP controlled room remperature
■ protect from heat, humidity, and light
Inactive ingredientscolloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62732-9009-1 | 2021-11-18 | C162847 | 48780-1 | 9d75b9cf-d3a0-f424-e053-dadaa90a57ce | Guaifenesin and Dextromethorphan HBr Tablets, 400 mg/20 mg |
| 62732-9009-2 | 2021-11-18 | C162847 | 48780-1 | 9d75b9cf-d3a0-f424-e053-dadaa90a57ce | Guaifenesin and Dextromethorphan HBr Tablets, 400 mg/20 mg |
| 62732-9009-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d3a0-f424-e053-dadaa90a57ce | Guaifenesin and Dextromethorphan HBr Tablets, 400 mg/20 mg |
| 62732-9009-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d3a0-f424-e053-dadaa90a57ce | Guaifenesin and Dextromethorphan HBr Tablets, 400 mg/20 mg |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 62732-9009 | 62732-9009-1, 62732-9009-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE K29/32 | 390RMW2PEQ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d108c36a-6a06-2793-e053-2995a90ae059 | 3d233b7c-1f46-5fd7-e054-00144ff8d46c | 2021-11-17 | Warnings | 3d233b7c-1f46-5fd7-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.