FDA Label for Bronco Silen-dm

View Indications, Usage & Precautions

Bronco Silen-dm Product Label

The following document was submitted to the FDA by the labeler of this product Caribe Natural, Llc. 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.

Active Ingredients (In Each 10Ml)



Dextromethorphan HBr 20 mg
Guaifenesin 400 mg


Purpose



Cough Suppressant

Expectorant


Uses



  • temporarily relieves cough due to minor throat and bronchial irritation may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings



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 health professional before taking this product.


Ask A Doctor Before Use If You Have



  • cough that occurs with to much phlegm (mucus)
  • cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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 reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.


Other Information



  • Store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients



Cherry Flavor, Citric Acid, FD&C red no. 40, Hydroxyethyl Cellulose, Menthol, Methylparaben, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and Sucralose


Questions:



Contact us Monday to Friday at (305) 256-1469 9:00am - 5:00pm EST.


Display Label



NDC 59561-202-04
GERMA
BRONCO-SILEN-DM
COUGH SUPPRESSANT
EXPECTORANT
Sugar FREE
Alcohol FREE
Non-Drowsy
New Improved Taste
Stronger than Leading Brands
Contents: 4 FL. OZ. (118 mL)


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