FDA Label for Dextromethorphan Hydrobromide And Guaifenesin

View Indications, Usage & Precautions

Dextromethorphan Hydrobromide And Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Opmx 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 Ingredient (In Each 5 Ml)                      Purpose



Dextromethorphan HBr USP 20 mg............. Cough suppressant

Guaifenesin, USP 300 mg............................... Expectorant


Uses



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

Ask A Doctor Before Use If You Have



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

Directions



  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • ml=milliliter
  • this adult product is not intended for use in children under 12 years of age
  • Age

    Dose

    Adults and children 12 years and over

    5 mL every 4 hours

    Children under 12 years

    do not use


Other Information



  • Store at 20°-25°C (68° -77°F). 
  • Do not refrigerate.
  • Retain carton for future reference on full labeling

Inactive Ingredients



citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol.


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