Label: VICKS VAPOCOOL SORE THROAT- benzocaine and menthol lozenge

  • NDC Code(s): 37000-935-16
  • 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 lozenge)

    Benzocaine 15 mg
    Menthol 20 mg

    Purpose

    Oral anesthetic

    Oral anesthetic

  • Uses

    temporarily relieves occasional minor irritation and pain due to

    • sore throat
    • sore mouth
  • Warnings

    Methemoglobinemia Warning–

    Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

    • pale, gray or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy
  • Allergy alert:

    do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

  • 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.

  • Do not use

    • for teething
    • in children under 2
  • When using this product

    do not exceed recommended dosage

  • 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.

  • 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 lozenge 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 room temperature; protect from moisture
    • contains soy
  • Inactive ingredients

    corn syrup, flavors, propylene glycol, sucrose

  • Questions?

    1-800-283-4879

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE,
    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 16 Lozenges Carton

    VICKS ®

    VapoCOOL

    SORE THROAT

    BENZOCAINE & MENTHOL - ORAL ANESTHETICS

    COOLING + NUMBING

    Soothes Throat Pain
    Fast-acting

    WINTERFROST

    16 LOZENGES

    935

  • INGREDIENTS AND APPEARANCE
    VICKS VAPOCOOL  SORE THROAT
    benzocaine and menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-935
    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) MENTHOL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize19mm
    FlavorMENTHOLImprint Code Vicks;logo
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-935-162 in 1 CARTON10/09/2019
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/09/2019
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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