Label: MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF- benzocaine and menthol, unspecified form spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Benzocaine 7%Oral pain reliever
    Menthol 1%Oral pain reliever
  • Uses

    temporarily relieves occasional minor irritation and pain associated with

    • sore throat
    • sore mouth
    • canker sores
  • 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.

    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.

    Do not use

    • for teething
    • in children under 6 years of age

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling, rash, or fever develops

    If pregnant or breast-feeding,ask a health professional before use.

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and
    children
    6 years of
    age and older     		apply to affected area (one spray); gargle, swish around in the mouth, or allow to remain in place at least 1 minute then spit out. Use up to 4 times daily or as directed by a doctor or dentist. Children 6 to under 12 years of age SUPERVISE USE
    children under 6 years of agedo not use
  • Other information

    • store at 20-25°C (68-77°F
  • Inactive ingredients

    anhydrous citric acid, cetylpyridinium chloride, dibasic sodium phosphate, edetate disodium, flavor, hydrochloric acid, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sucralose

  • Questions?

    (1-866-682-4639)You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

    Made in Canada

  • PRINCIPAL DISPLAY PANEL - 115 mL Bottle Label

    NDC 72854-265-04
    ALCOHOL-FREE

    Mucinex®
    INSTASOOTHE™

    SORE THROAT
    + PAIN RELIEF

    Benzocaine 7% | Oral Pain Reliever
    Menthol 1% | Oral Pain Reliever

    • Numbs Pain Fast
    • Two Powerful
      Pain Relievers

    3.8 FL OZ (115 mL)
    500 Doses
    CHERRY
    FLAVOR SPRAY

    031121
    3184012

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    MUCINEX INSTASOOTHE  SORE THROAT PLUS PAIN RELIEF
    benzocaine and menthol, unspecified form spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-265
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7 g  in 100 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-265-04115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2021
    Labeler - RB Health (US) LLC (081049410)
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