Label: MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF- dextromethorphan hydrobromide and hexylresorcinol lozenge

  • NDC Code(s): 72854-263-20, 72854-263-40
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 15, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each lozenge)Purposes
    Dextromethorphan HBr 5.0 mgCough suppressant
    Hexylresorcinol 2.0 mgOral pain reliever
  • Uses

    temporarily relieves

    • cough due to minor throat and bronchial irritation as may occur with the common cold
    • occasional irritation and pain due to a sore mouth or sore throat
    • pain associated with canker sores
  • Warnings

    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

    • 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 contains an MAOI, ask a doctor or pharmacist before taking this product.
    • in children under 6 years of age

    When using this productdo not exceed recommended dosage

    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 and ask a doctor or dentist 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 condition.

    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

    dose as follows or as directed by a doctor or dentist

    adults and children 12 years of age and oldertake 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in any 24-hour period
    children 6 to under 12 years of agetake 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in any 24-hour period
    children under 6 years of agedo not use
  • Other information

    • store at 20-25°C (68-77°F)
    • protect contents from humidity
  • Inactive ingredients

    corn syrup, D&C yellow no. 10, ethyl lactate, FD&C blue no. 1, flavor, propylene glycol, purified water, sucrose.

  • Questions?

    1-866-MUCINEX (1-866-682-4639)

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 20 Drop Pouch Bag

    NDC 72854-263-20

    Mucinex®
    INSTASOOTHE™

    SORE THROAT
    + COUGH RELIEF

    Dextromethorphan HBr 5.0 mg | Cough Suppressant
    Hexylresorcinol 2.0 mg | Oral Pain Reliever

    3 IN 1 FORMULA

    ✔ Up to 4 Hours Cough Relief
    ✔ Cooling Comfort
    ✔ Fast Acting

    See back
    panel for
    actual size

    Winter Mint Flavor

    20 MEDICATED DROPS

    Front LabelBack Label

  • INGREDIENTS AND APPEARANCE
    MUCINEX INSTASOOTHE  SORE THROAT PLUS COUGH RELIEF
    dextromethorphan hydrobromide and hexylresorcinol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-263
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
    HEXYLRESORCINOL (UNII: R9QTB5E82N) (HEXYLRESORCINOL - UNII:R9QTB5E82N) HEXYLRESORCINOL2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ETHYL LACTATE (UNII: F3P750VW8I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorturquoiseScoreno score
    ShapeROUNDSize18mm
    FlavorMINTImprint Code S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-263-2020 in 1 BAG07/01/2021
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:72854-263-4040 in 1 BAG07/01/2021
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02207/01/2021
    Labeler - RB Health (US) LLC (081049410)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!