FDA Label for Original Menthol And Eucalyptus Sugar Free

View Indications, Usage & Precautions

Original Menthol And Eucalyptus Sugar Free Product Label

The following document was submitted to the FDA by the labeler of this product Valda Usa Labeler. 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.

Drug Facts



Purpose

Cough suppressant, oral anesthetic


Active Ingredient (In Each Drop)



Menthol, 3.6 mg


Uses



Temporarily relieves:

  • Minor sore throat
  • Cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants

Warnings



Sore throat warning: If sore throat is severe and persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These symptoms may be serious.


Ask Doctor Before Use If You Have



  • Persistent chronic cough such as occurs with smoking, asthma, or emphysema
  • Cough accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor If



  • Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
  • Sore mouth does not improve in 2 days
  • Irritation, pain, or redness persists or worsens

Keep Out Of Reach Of Children.





Directions



  • Adults and children 5 years and over:  Dissolve 2 drops (one at a time) slowly in mouth.  Repeat every 2 hours as needed.
  • Children under 5 years of age: Ask a doctor.

Inactive Ingredients



Curcumin, eucalyptus globulus, FD&C Blue No. 1, glycerin, gum arabic, purified water, sorbitol, vegetable oil, white beeswax, xylitol


Questions?



Or to report adverse events call 1-877-349-9443


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