Label: VICKS VAPOCOOL SEVERE- menthol lozenge

  • NDC Code(s): 69423-797-18, 69423-797-45
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (per drop)

    Menthol 20 mg

    Purpose

    Oral anesthetic

  • Uses

    temporarily relieves occasional minor irritation and pain due to

    • sore throat
    • sore mouth
  • Warnings

    Sore Throat Warning –

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

  • Ask a doctor before use if you have

    • a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days
    • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
  • Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

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

  • Directions

    • adults and children 12 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
    • children under 12 years, do not use.
  • Other information

    • Store at 20°-25°C (68°-77°F) in a dry place
    • contains soy
  • Inactive ingredients

    beta carotene, corn syrup, flavors, honey, sucrose, water

  • Questions?

    1-800-707-1709

  • SPL UNCLASSIFIED SECTION

    DIST. BY:

    PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 45 drops in a bag

    STARTS WORKING IN SECONDS!

    VICKS®

    VapoCOOL ™

    SEVERE

    MENTHOL • ORAL ANESTHETIC

    MAX STRENGTH • FAST RELIEF

    SOOTHES SORE THROAT

    HONEY LEMON CHILL

    45 MEDICATED DROPS

    797

  • INGREDIENTS AND APPEARANCE
    VICKS VAPOCOOL  SEVERE
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-797
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    HONEY (UNII: Y9H1V576FH)  
    WATER (UNII: 059QF0KO0R)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SUCROSE (UNII: C151H8M554)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize23mm
    FlavorHONEY (Lemon) Imprint Code vapor
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-797-1818 in 1 BAG07/03/2021
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69423-797-4545 in 1 BAG07/03/2021
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02207/03/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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