Indications and uses
Temporarily relieves cough due to minor throat and bronchial irritation as may occour with a cold. Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Temporarily relieves cough due to minor throat and bronchial irritation as may occour with a cold. Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Do not take more than 6 doses in any 24 hour period. age dose Adults and children 12 years and over 2 TSP (teaspoonful) every 4 hours children under 12 years do not use
sodium- 2mg Each TSP (5ml) contains: Store at 20-25° C (68-77° F) Dosage cup provided
| (in each TSP (5 mL)) Active ingredients | Purpose |
|---|---|
| Dextromethorphan HBr USP 10 mg | Cough suppressant |
| Guaifenesin USP 100 mg | Expectorant |
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinsons disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product. Do not use:
Cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
ask a health professional before use. If pregnant or breast feeding:
In case of overdose , get medical help or contact a Poison Control center right away. Keep out of reach of children.
Do not take more than 6 doses in any 24 hour period.
| age | dose |
|---|---|
| Adults and children 12 years and over | 2 TSP (teaspoonful) every 4 hours |
| children under 12 years | do not use |
artificial flavor, citric acid, glycerin, menthol, polyethylene glycol 1450, povidone, propylene glycol, purified water, sodium benzoate, sucralose.
1-800-616-2471
Distributed by: 31778 Enterprise Drive Livonia, MI 48150 USA
MAJOR PHARMACEUTICALS
®
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 3 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 3 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 3 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 3 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 3 |
| 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 |
|---|---|---|---|
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-6306-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4c96-f424-e053-dadaa90a57ce | Robafen DM Cough Sugar Free Clear ® |
| 17856-6306-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4c96-f424-e053-dadaa90a57ce | Robafen DM Cough Sugar Free Clear ® |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-6306-1 | Robafen DM Cough Sugar Free Clear | 10 mL in 1 CUP | SOLUTION | 10 | 3 | |
| 17856-6306-5 | Robafen DM Cough Sugar Free Clear | 5 mL in 1 CUP | SOLUTION | 5 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-6306 | ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | Legacy NDC, 2 package rows | 20160722_ab0f8f18-cce4-41e9-957e-e9396966094a.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-6306-5 | ML - Milliliter | 17856-6306 | b4c004d5-826d-47b9-b404-71bff4d77b2f | 1 | 2016-05-16 |
| 0904-6306-20 | ML - Milliliter | 0904-6306 | 5d14d06c-f4e4-41c1-babf-c3e7cf0e3ad1 | 1 | 2014-11-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 17856-6306 | 17856-6306-5, 17856-6306-1 |
| 0904-6306 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Guaifenesin | 495W7451VQ | ACTIB |
| Dextromethorphan Hydrobromide | 9D2RTI9KYH | ACTIB |
| Sodium Benzoate | OJ245FE5EU | IACT |
| Polyethylene Glycols | 3WJQ0SDW1A | IACT |
| Anhydrous Citric Acid | XF417D3PSL | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Propylene glycol | 6DC9Q167V3 | IACT |
| Povidones | FZ989GH94E | IACT |
| Menthol | L7T10EIP3A | IACT |
| Prunus Serotina Bark | 5D48E975HA | IACT |
| Sucralose | 96K6UQ3ZD4 | IACT |
| Water | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| a7dc60f8-6b87-42c8-9163-26db09d1d72c | ab0f8f18-cce4-41e9-957e-e9396966094a | 2016-07-22 | Warnings | a7dc60f8-6b87-42c8-9163-26db09d1d72c ab0f8f18-cce4-41e9-957e-e9396966094a |
Adverse event summaries are temporarily unavailable. Other product information remains available.