OTC - ACTIVE INGREDIENT SECTION
Dextromethorphan HBr 20mg
Guaifenesin 400mg
Dextromethorphan HBr 20mg
Guaifenesin 400mg
microcrystalline cellulose, sodium starch glycolate, talc, colloidal silicon dioxide,magnesium stearate, polyvinyl povidone, maltodextrin, stearic acid
* May contain hydroxypropyl methylcellulose, polyethylene glycol
* take with a full glass of water
* swallow whole; do not crush, chew or dissolve
*do not take more than 6 tablets in 24 hours
| adults and children 12 years of age and over | 1 tablet every 4 hours |
| children under 12 years of age | Do not use |
* temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
* helps loosen phlegm (mucus) and thin bronchial secretions to 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 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 condition.
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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Cough Suppressant
Expectorant
* store at room temperature 25°C (77°F) ; excursions permitted between 15°C - 30°C (59°F - 86°F)
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70692-101-24 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9691-a426-e053-dadaa90af4c2 | Dextromethorphan HBr 20mg and Guaifenesin 400mg |
| 70692-101-41 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9691-a426-e053-dadaa90af4c2 | Dextromethorphan HBr 20mg and Guaifenesin 400mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70692-101-24 | Cough Mucus Relief DM | 24 in 1 BOTTLE | TABLET | 24 | 4 | |
| 70692-101-41 | Cough Mucus Relief DM | 4 in 1 PACKAGE | TABLET | 4 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70692-101 | 70692-101-24, 70692-101-41 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| b193b6ae-555b-7d3e-e053-2a95a90a6814 | 6878aed8-df32-19f1-e053-2991aa0a614e | 2020-10-13 | Warnings | b193b6ae-555b-7d3e-e053-2a95a90a6814 6878aed8-df32-19f1-e053-2991aa0a614e |
Adverse event summaries are temporarily unavailable. Other product information remains available.