Label: FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS- menthol suspension/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 8, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient

     Menthol 2.7mg

  • Purpose

    Cough Suppressant / Oral anesthetic

  • Use

    • Cough as may occur with a cold
    • Occasional minor irritation and sore throat
  • Warning

    Sore throat warning : if sore throat is severe, persists for more than 2 days, is accompanied or followed 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 promptly. These symptoms may be serious.

    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 7 days, 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

    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 2 lozenges (one at a time) 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 bag is torn or open 
    • Contains : Soy
  • Inactive ingredients

    Citric acid, corn syrup, eucalyptus oil, FD&C red no. 40, natural & artificial flavoring, soy lecithin, sucrose and water.

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS 
    menthol suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83002-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.7 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScore    
    ShapeOVALSize15mm
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83002-001-019 in 1 CARTON11/15/2022
    130 in 1 BAG
    11 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/15/2022
    Labeler - R.L. ALBERT & SON, INC (005900899)
    Establishment
    NameAddressID/FEIBusiness Operations
    Riclan S.A.911989788manufacture(83002-001)