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Rabofen Dm
FDA Label NDC 50090-2657
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Rabofen Dm (NDC 50090-2657). 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 other, otc - purpose, uses, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 2 TSP (10 mL)) | Purposes |
|---|---|
| Dextromethorphan HBr, USP 20 mg | Cough suppressant |
| Guaifenesin, USP 200 mg | Expectorant |
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Otc - Do Not Use
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
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus).
Otc - Stop Use
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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period
- use enclosed dosing cup only. Do not use any other device.
- this adult product is not intended for use in children under 12 years of age
- TSP=teaspoonful
| adults and children 12 years and over | 2 TSP every 4 hours |
| children under 12 years | do not use |
Other Information
- each TSP (5 mL) contains: sodium 3 mg
- store at 20°-25°C (68°-77°F). Do not refrigerate
Tamper-Evident
Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
Inactive Ingredients
artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate
Questions Or Comments?
(800)-616-2471
How Supplied
Product: 50090-2657
NDC: 50090-2657-0 118 mL in a BOTTLE
* Please review the disclaimer below.
