VICKS VAPOCOOL SEVERE (MENTHOL) LOZENGE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]

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VICKS VAPOCOOL SEVERE (MENTHOL) LOZENGE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 37000-894-18
Set ID 6249abb0-8972-16a5-e053-2991aa0a09fb
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class
Product Number
Application Number PART356
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per drop)

    Menthol 20 mg

  • Purpose

    Oral anesthetic

  • Uses

    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 5 years of age unless directed by doctor.

    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. 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. May contain Peanuts, Milk,Wheat, Nuts or Tree Nuts
  • 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 - 20 Drop Bag

    MAX

    STRENGTH

    VICKS®

    VapoCOOL™

    SEVERE

    MENTHOL ·ORAL ANESTHETIC

    WINTERFROST

    • Powerful Rush of Vicks Vapors
    • Soothes Sore Throats
    • 33% More Medicine*

    18 MEDICATED DROPS

    894 NEW

  • INGREDIENTS AND APPEARANCE
    VICKS VAPOCOOL  SEVERE
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-894
    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 VICKS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-894-1818 in 1 BAG12/29/2017
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:37000-894-4545 in 1 BAG12/29/2017
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:37000-894-20200 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 not finalpart35612/29/2017
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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