Label: CHLORASEPTIC TOTAL SORE THROAT AND COUGH- menthol and benzocaine and dextromethorphan hydrobromide lozenge

  • NDC Code(s): 67172-016-11
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 23, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    (in each lozenge)

    Benzocaine 6 mg

  • Purpose

    Oral pain reliever

  • Active ingredients

    (in each lozenge)

    Dextromethorphan HBr 5 mg

  • Purpose

    Cough Suppressant

  • Active ingredients

    (in each lozenge)

    Menthol 10 mg

  • Purpose

    Oral pain reliever

  • Uses

    Temporarily relieves:

    • occasional minor irritation, pain, sore throat and sore mouth
    • cough due to minor throat and bronchial irritation as may occur with the common cold
  • 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 6 years of age unless directed by a doctor.

    Do not use

    • this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product
    • for teething
    • in children under 6 years of age

    Ask a doctor before use if you have

    • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema 
    • a cough is accompanied by excessive phlegm (mucus)

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a dentist or doctor if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops
    • cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours.
    • Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours.
    • Children under 6 years of age: do not use
  • Other information

    • Store between 15ºC - 30º (59ºF - 86ºF)
    • Protect from moisture.
    • Check expiration date before using.
  • Inactive ingredients

    Corn Syrup, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Glycerin, Soy Lecithin, Sucrose, Water

  • Questions?

    1-800-552-7932 or www.chloraseptic.com

  • PRINCIPAL DISPLAY PANEL

    Chloraseptic® Total SORE THROAT + COUGH Lozenges
    Menthol/Benzocaine Oral Anesthetic/Analgesic
    Dextromethorphan HBr Cough Suppressant
    15 lozenges | Wild Cherry

    PRINCIPAL DISPLAY PANEL Chloraseptic® Total SORE THROAT + COUGH Lozenges Menthol/Benzocaine Oral Anesthetic/Analgesic Dextromethorphan HBr Cough Suppressant 15 lozenges | Wild Cherry

  • INGREDIENTS AND APPEARANCE
    CHLORASEPTIC TOTAL SORE THROAT AND COUGH 
    menthol and benzocaine and dextromethorphan hydrobromide lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize4mm
    FlavorCHERRYImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-016-111 in 1 CARTON08/01/2010
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02208/01/2010
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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