Label: FREEGELLS COUGH DROPS MENTHOL EUCALYPTUS- menthol lozenge

  • NDC Code(s): 71165-012-00, 71165-012-01
  • Packager: Riclan S.A.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient (in each drop)

    Menthol 5.4 mg

    Purpose

    Cough suppressant/ Oral anesthetic

  • Uses

    temporarily relieves:

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

    if sore throat is severe, persists for more than 2 days, is accompained or follwed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promtly. These symptoms may be serious. Sore throat warning:

    Ask a doctor before use if you have:

    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompained by excessive phlegm (mucus)

    Stop use ask doctor if

    • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serius condition.
    • sore throat is severe, or irritation, pain o redness lasts or worsens
    • sore mouth does not improve in 7 days

    If pregnant or breast-feeding, 

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

     adults and children 5 years and over

     dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
     children under 5 years  ask a doctor 

  • Other information

    • 11 calories per drop
    • do not use if bags is torn or open
    • Contains: Soy.
  • Inactive ingredients:

    corn syrup, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, gum arabic, maltodextrin, natural flavor, soy lecithin, sucrose and water.

  • Package Labeling:71165-012-00

    Label2

  • Package Labeling:71165-012-01

    Label03

  • INGREDIENTS AND APPEARANCE
    FREEGELLS COUGH DROPS MENTHOL EUCALYPTUS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71165-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize20mm
    FlavorMENTHOL (EUCALYPTUS) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71165-012-0030 in 1 BAG; Type 0: Not a Combination Product10/01/2022
    2NDC:71165-012-0180 in 1 BAG; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2022
    Labeler - Riclan S.A. (911989788)
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