Label: MIXED BERRY SORE THROAT AND COUGH LOZENGE- benzocaine lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 15, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients ( in each lozenge)

    Benzocaine 7.5 mg

    Dextromethorphan hydrobromide 5 mg

  • PURPOSE

    Purpose

    Oral pain reliever

    Cough suppressant

  • INDICATIONS & USAGE

    Uses temporarily relieves these symptoms:

    occasional minor mouth irritation, sore mouth and sore throat

    cough due to minor throat and bronchial irritation as may occur with the common cold

  • WARNINGS

    Warnings

    Methemoglobinemia warning:

    Use of this product may cause methemoglobinemia, a serious conditin 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 of 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, persists 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 anesthetics such as procaine, butacaine, benzocaine, or other "caine: anesthetics.

  • DO NOT USE

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug is an MAOI, ask a doctor or pharmacist before taking this product.

    • for teething
    • in children under 2 years of age
  • ASK DOCTOR

    Ask a doctor before use if you have:

    persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    cough that occurs with too much phlegm (mucus)

  • STOP USE

    Stop use and ask doctor if

    sore mouth symptoms do not improve in 7 days

    irritation, pain, or redness persists or worsens

    swelling develops

    cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness

  • PREGNANCY OR BREAST FEEDING

    If pregnant of 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 12 years and older - allow 2 lozenges to dissolve slowly in mouth, one at a time; may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor

    children 6 to 12 years of age - take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor

    children under 6 years of age - do not use

  • INACTIVE INGREDIENT

    Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C blue no. 1, FD&C red no. 40, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

  • OTHER SAFETY INFORMATION

    Other information

    store at room temperature

    protect from moisture

  • QUESTIONS

    Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9am to 4pm EST

  • PRINCIPAL DISPLAY PANEL

    Walgreens Mixed Berry Benz-Dex 18ct Lozenges

  • INGREDIENTS AND APPEARANCE
    MIXED BERRY SORE THROAT AND COUGH LOZENGE 
    benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize17mm
    FlavorBERRYImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1080-1818 in 1 BLISTER PACK; Type 0: Not a Combination Product01/19/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/19/2016
    Labeler - Walgreen Company (008965063)
    Registrant - Bestco Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco Inc.002149136manufacture(0363-1080)