Label: EQUATE BENZ-DEX COUGH AND THROAT LOZENGES- 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 October 4, 2023

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

    Purposes

    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 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

    Sore throat warning: If sore threat 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 persist or worsens, see your dentist or doctor promptly.

  • DO NOT USE

    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 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 you prescription drug contains 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 accurs 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 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

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature
    • protect from moisture
  • INACTIVE INGREDIENT

    Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C Blue 1, FD&C Red 40, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

  • QUESTIONS

    Questions? 1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    Equate Mixed Berry Benz-Dex 18ct Lozenges

  • INGREDIENTS AND APPEARANCE
    EQUATE BENZ-DEX COUGH AND THROAT LOZENGES 
    benzocaine lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-042
    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
    Colorred (Dark Red) Scoreno score
    ShapeROUNDSize17mm
    FlavorBERRYImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-042-1818 in 1 BLISTER PACK; Type 0: Not a Combination Product04/23/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/23/2021
    Labeler - Walmart (051957769)
    Registrant - Bestco LLC (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco LLC002149136manufacture(79903-042)