Label: VICKS VAPOCOOL SEVERE WINTERFROST- menthol lozenge

  • NDC Code(s): 37000-597-18, 37000-597-20, 37000-597-45
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (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.
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    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 12 years and under: do not use
  • Other information

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

    corn syrup, eucalyptol, FD&C Blue No. 1, flavors, glycerin, gum arabic, potassium sorbate, sucrose, water

  • Questions?

    1-800-707-1709

  • SPL UNCLASSIFIED SECTION

    Distributed by

    Procter & Gamble

    Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL

    MAX

    STRENGTH

    VICKS®

    VapoCOOL™

    SEVERE

    MENTHOL ·ORAL ANESTHETIC

    WINTERFROST

    Powerful Vicks Vapors

    Soothes Sore Throats

    18 MEDICATED DROPS

    596

  • INGREDIENTS AND APPEARANCE
    VICKS VAPOCOOL  SEVERE WINTERFROST
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-597
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    ACACIA (UNII: 5C5403N26O)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (with blue specks) Scoreno score
    ShapeOVALSize23mm
    FlavorMENTHOLImprint Code vapor
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-597-1818 in 1 BAG12/29/2017
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:37000-597-4545 in 1 BAG12/29/2017
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:37000-597-20200 in 1 BAG07/09/2019
    31 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/29/2017
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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