Label: KOFIX CHERRY AND BLACKBERRY- menthol lozenge

  • 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 January 7, 2022

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

  • Drug Facts

  • Active ingredient (in each lozenge)

    Menthol 8 mg

  • Purpose

    Cough suppressant / Oral anesthetic

  • Uses

    for the temporary relief of  •  cough occurring with a cold  •  occasional minor irritation, pain, sore mouth, and sore throat

  • Warnings

    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by physician

    Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is  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 throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
    • sore mouth symptoms do not improve in 7 days  •  irritation, pain, or redness persists or worsens

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

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

  • Directions

    • adults and children 5 years and over: dissolve one lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
    • children under 5 years of age: ask a doctor

  • Other information

    •  store at a cool and dry place 20ºC - 25ºC (68ºF - 77ºF) •  protect from heat, humidity and direct sunlight

  • Inactive ingredients

    anethole, blackberry flavor, black currant liquid extract, carmine, cherry flavor, citric acid, clove oil, cornstarch, eucalyptus oil, gum arabic, sugar

  • Questions?

    +1-800-550-4741, You may also report serious side effects to this phone number. Monday to Friday, 9 AM - 6 PM EST.

  • SPL UNCLASSIFIED SECTION

    MENTHOL COUGH SUPPRESSANT/ ORAL ANESTHETIC

    SORE THROAT RELIEF

    CHERRY AND BLACKBERRY FLAVOR

    8.2 calories per lozenge

    MADE IN TURKEY

    Distributed by:

    Global Health Solution LLC,
    8328 Kings Ridge Court,
    Springfield, VA 22153

  • Packaging

    KOFIXGLOBAL-6

  • INGREDIENTS AND APPEARANCE
    KOFIX CHERRY AND BLACKBERRY 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82340-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANETHOLE (UNII: Q3JEK5DO4K)  
    BLACK CURRANT JUICE (UNII: 9L8NK01P32)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CLOVE OIL (UNII: 578389D6D0)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize19mm
    FlavorCHERRY, BLACKBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82340-002-242 in 1 BOX11/01/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:82340-002-041 in 1 BOX01/06/2022
    24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2021
    Labeler - Global Health Solution LLC (117922627)