FDA Label for Robafen Dm Cough Sugar Free Clear

View Indications, Usage & Precautions

Robafen Dm Cough Sugar Free Clear Product Label

The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corps. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



(in each TSP (5 mL)) Active ingredientsPurpose
Dextromethorphan HBr USP 10 mgCough suppressant
Guaifenesin USP 100 mgExpectorant

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.

agedose
Adults and children 12 years and over2 TSP (teaspoonful) every 4 hours
children under 12 yearsdo 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



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