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  5. Label Information: Menthol Drops Freegells Extra Strong Eucalyptus 30ct

FDA Label for Menthol Drops Freegells Extra Strong Eucalyptus 30ct

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNING
    5. KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PRODUCT LABEL

Menthol Drops Freegells Extra Strong Eucalyptus 30ct Product Label

The following document was submitted to the FDA by the labeler of this product R.l. Albert & Son, Inc. 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 20 mg


Purpose



Oral anesthetic


Use



Temporarily relieves occasional minor irritation and pain due to:

  • sore throat
  • sore mouth

Warning



Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

Ask a doctor before use if you have :

  • a severe sore throat accompanied by difficult in breathing or that lasts more than 2 days.
  • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting.

    • Stop use and ask doctor if 

    • sore mouth symptoms do not improve in 7 days or if irritation, pain or redness lasts or worsens

      • If pregnant or breast-feeding, ask a health professional before use.


Keep Out Of Reach Of Children. In Case Of Overdose, Get Medical Help Or Contact A Poison Control Center Right Away.




Directions



 Adults and children 12 years and over dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor
 children under 12 years do not use.


Other Information



  • 11 calories per drop  
  • Do not use if the bag is torn or open. 
  • Contains: Soy

Inactive Ingredients



Artificial flavors, corn syrup, eucalyptus oil, FD&C Blue No. 1, FD&C Red No. 40,  Gum Arabic, Maltodextrin, Soy Lecithin, sucrose and water.


Product Label



image description - images 011

image description - images 011


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