Otc - Purpose
| (in each TSP (5 mL)) Active ingredients | Purpose |
|---|---|
| Dextromethorphan HBr USP 10 mg | Cough suppressant |
| Guaifenesin USP 100 mg | Expectorant |
Robafen Dm Cough Sugar Free Clear
FDA Label NDC 17856-6306
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corps for the product Robafen Dm Cough Sugar Free Clear (NDC 17856-6306). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, uses, otc - do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Do Not Use
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:
Ask A Doctor Before Use If You Have
- Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
- Cough occurs with too much phlegm (mucus)
Stop Use And Ask A Doctor If
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.
Otc - Pregnancy Or Breast Feeding
ask a health professional before use. If pregnant or breast feeding:
Otc - Keep Out Of Reach Of Children
In case of overdose , get medical help or contact a Poison Control center right away. Keep out of reach of children.
Directions
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 |
Other Information
- sodium- 2mg Each TSP (5ml) contains:
- Store at 20-25° C (68-77° F)
- Dosage cup provided
Inactive Ingredients
artificial flavor, citric acid, glycerin, menthol, polyethylene glycol 1450, povidone, propylene glycol, purified water, sodium benzoate, sucralose.
Questions Or Comments?
1-800-616-2471
Other
Distributed by: 31778 Enterprise Drive Livonia, MI 48150 USA
MAJOR PHARMACEUTICALS
®
* Please review the disclaimer below.
