Label: SORE THROAT LOGENZES SORE THROAT- benzocaine and menthol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each lozenge)Purpose
     Benzocaine 15 mg Oral pain reliever
     Menthol 3.6 mg Oral pain reliever
  • Uses

    temporary relief of occasional

    • sore throat
    • sore mouth
    • minor mouth irritation
    • pain associated with canker sores
  • Warnings

    Allergy alert

    • Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.

    Sore throat warning

    • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

    Do not use in a child under 5 years of age.

    Stop use and ask a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops

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

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

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not exceed recommended dosage.

  • Directions

    • adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
    • children under 5 years of age: ask a doctor
  • Other information

    • tamper evident packaging: Do not use if outer box or blister is open or damaged. 
    • store at room temperature
    • protect contents from moisture
  • Inactive ingredients

    Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.

  • Questions?

    Call 1-800-616-2471

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    Major Pharmaceuticals
    Livonia, MI 48150  USA

  • PRINCIPAL DISPLAY PANEL- 16 Lozenge Carton

    NDC 0904-6255-49

    MAJOR SORE THROAT LOZENGES

    Fast, Long Lasting Relief

    Benzocaine 15 mg | Menthol 3.6 mg
    Oral Pain Reliever

    18 Lozenges

    cherry

    front1drugfacts1

  • INGREDIENTS AND APPEARANCE
    SORE THROAT LOGENZES  SORE THROAT
    benzocaine and menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6255
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    ALLYL SUCROSE (UNII: VI3D59RW0U)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize18mm
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6255-4918 in 1 CARTON12/28/2012
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/28/2012
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco, Inc.002149136manufacture(0904-6255)
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