Label: MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC COUGH DROPS- menthol lozenge

  • NDC Code(s): 61658-110-30, 61658-110-80
  • Packager: YUNNAN BAIYAO GROUP CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 7, 2024

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

  • Drug Facts

  • Active ingredient (in each lozenge)

    Menthol 5.4 mg

  • Purposes

    Cough suppressant/oral anesthetic

  • Uses

    temporarily relieves:
    • cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

  • Warnings

    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.

    Ask a doctor before use if you have
    • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if
    • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens

    Keep this and all drugs out of the reach of children.

  • Directions

    • adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
    • children under 2 years of age: ask a doctor

  • Other information

    • store at room temperature.
    • keep away from excessive heat or sunlight
    • do not use if primary bag seal has been torn or broken.
    • contains: SOY

  • Inactive ingredients

    citric acid, corn syrup, eucalyptus oil, FD&C blue 1, FD&C red 40, menthol flavor, potassium citrate, soy lecithin, sucralose, sucrose, water.

  • Questions or comments?

    Call +1-866-306-9136
    You may also report concerns to this phone number
    Monday to Friday, 9 AM -5 PM Eastern Time or visit our website at www.mgc.us

  • SPL UNCLASSIFIED SECTION

    RESEALABLE BAG

    COMPARE TO ACTIVE INGREDIENT OF HALLS®

    MENTHOL FLAVOR

    √ SOOTHING DROPS
    √ GLUTEN FREE
    √ DAIRY FREE

    CLOSE BAG TO MAINTAIN FRESHNESS

    DISTRIBUTED BY: 
    MEDICAL GROUP CARE, LLC
    NAPLES, FL 34110

    MADE IN CHINA

    This product is not manufactured or distributed by
    Intercontinental Great Brands LLC., owner of the registered trademark HALLS®

    Contains 12 calories per lozenge
    customerservice@mgc.us

    CHOKING HAZARD:
    • SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4.
    • CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.

  • Packaging

    Cough Drops

  • INGREDIENTS AND APPEARANCE
    MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61658-110
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize21mm
    FlavorMENTHOLImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61658-110-3030 in 1 BAG; Type 0: Not a Combination Product06/21/2024
    2NDC:61658-110-8080 in 1 BAG; Type 0: Not a Combination Product06/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/21/2024
    Labeler - YUNNAN BAIYAO GROUP CO.,LTD (654223122)