Menthol Drops Freegells Extra Strong Eucalyptus 30ct Lozenge
FDA Label NDC 83002-011

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by R.l. Albert & Son, Inc for the product Menthol Drops Freegells Extra Strong Eucalyptus 30ct (NDC 83002-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warning, keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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