FDA Label for Cough Drops Gems Flawless Cherry Flavor 30ct

View Indications, Usage & Precautions

Cough Drops Gems Flawless Cherry Flavor 30ct Product Label

The following document was submitted to the FDA by the labeler of this product Riclan S.a.. 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



Menthol


Purpose



Cough Suppressant / Oral anesthetic


Use



Temporarily relieves:

  • cough as may occur with a cold 
  • occasional minor irritation and sore throat

Warnings



Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor Promptly. Do not use more than 2 days unless directed by a doctor.

Ask a doctor before use if you have :

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanined by excessive phlegm (mucus)
  • stop use and ask 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 throat is severe, or irritation, pain or redness lasts or worsens
    • sore mouth does not improve in 7 days

Keep Out Of Reach Of Children




Directions



  • do not take more than directed 
  • adults and children 5 years and over : dissolve 1 drop slowly in the mouth. Repeate every 2 hours as needed.
  • children under 5 years : ask a doctor

Other Information



  • 12 calories per drop 
  • Contains : Soy

Inactive Ingredients



corn syrup, eucalyptus oil, natural & artificial flavors, soy lecithin, sucrose and water, FD & C red #40


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