Label: CHERRY SORE THROAT LOZENGE- benzocaine lozenge

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 28, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients (in each lozenge)

    Benzocaine 15 mg

    Menthol 3.6 mg

  • PURPOSE

    Purpose

    Oral anesthetic

    Oral anesthetic

  • INDICATIONS & USAGE

    Uses temporarily relieves these symptoms:

    occasional minor irritation, pain, sore mouth and sore throat

  • WARNINGS

    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 attension 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

    Sore throat warning: If sore throat is severe, persistent for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

    Allergy alert: Do not use this product if you have a history of allergy to local anesthethics such as procaine, butacine, benzocaine, or other "caine" anesthetics.

  • DO NOT USE

    Do not use

    • for teething
    • in children under 2 years of age
  • STOP USE

    Stop use and ask doctor if

    sore throat is severe or irritation, pain or redness persists or worsens

    sore mouth symptoms do not improve in 7 days

  • 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 Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 5 years and older - allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.

    children under 5 years - do not use

  • OTHER SAFETY INFORMATION

    Other information

    store at room temperature

    protect from moisture

  • INACTIVE INGREDIENT

    Inactive ingredients: Corn starch, FD&C Red #40, glucose syrup, glycerin, medium chain triglycerides, natural & artificail flavors, propylene glycol, soybean oil, sucrose and water.

  • QUESTIONS

    Questions? Call 1-800-245-2898, Monday through Friday, 9AM - 4PM EST

  • PRINCIPAL DISPLAY PANEL

    Walgreens Cherry Benzocaine 18ct Throat Lozenge

  • INGREDIENTS AND APPEARANCE
    CHERRY SORE THROAT LOZENGE 
    benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1079
    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
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeROUNDSize17mm
    FlavorCHERRYImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1079-1818 in 1 BLISTER PACK; Type 0: Not a Combination Product04/15/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/15/2016
    Labeler - Walgreens Co. (008965063)
    Registrant - BestCo Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(0363-1079)