Label: ROBITUSSIN MEDI-SOOTHERS- dextromethorphan hydrobromide, menthol lozenge

  • NDC Code(s): 0031-9306-01, 0031-9306-02
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 19, 2024

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  • Active ingredients (in each lozenge)

    Dextromethorphan HBr 5 mg

    Menthol 5 mg

  • Purposes

    Cough suppressant

    Oral anesthetic

  • Uses

    temporarily relieves

    • cough due to minor throat and bronchial irritation as may occur with the common cold
    • occasional minor irritation, pain, sore mouth, and sore throat
  • 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 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.

    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

    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens

    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 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. Allow each lozenge to dissolve slowly in the mouth.
    • do not take more than 12 lozenges in any 24-hour period, or as directed by a doctor
    • children under 12 years of age: do not use
  • Other information▅ store at 20°-25°C (68°-77°F)

  • Inactive ingredients

    acacia, ascorbyl palmitate, beta carotene, caramel color, corn syrup, dl-alpha tocopherol, glycerin, maltodextrin, medium-chain triglycerides, natural flavors, natural grade A honey, propylene glycol, purified water, soy lecithin, sucralose, sucrose, sunflower oil

  • Questions or comments?

    call weekdays from 8 am to 6 pm EST at 1-800-245-1040

  • Additional Information

    PARENTS:

    Learn about teen medicine abuse

    www.StopMedicineAbuse.org

    Keep carton for complete information.

    Do not use if blister is broken or damaged.

    Distributed by: Haleon, Warren, NJ 07059

    Trademarks owned or licensed by Haleon.

    ©2023 Haleon or licensor.

    For more recent product information, visit www.robitussin.com

  • Principal Display Panel

    NEW! ADULT

    Robitussin

    Honey

    MEDI-SOOTHERS

    DEXTROMETHORPHAN HBr (Cough Suppressant) 5 mg

    Menthol (Oral Anesthetic) 5 mg

    Cough + Sore Throat

    Taste the Real Honey

    • Relieves Cough for up to 4 HOURS
    • Relieves Sore Throat Pain

    Honey Lemon Flavor

    Actual Size

    For Ages 12+

    16 MEDICATED LOZENGES

    202556 Front Carton

    Robitussin Medi-Soothers Honey Lemon 16 Medicated Lozenges

  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN MEDI-SOOTHERS 
    dextromethorphan hydrobromide, menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9306
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    CARAMEL (UNII: T9D99G2B1R)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HONEY (UNII: Y9H1V576FH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize25mm
    FlavorHONEY (Honey Lemon) Imprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-9306-018 in 1 BLISTER PACK; Type 0: Not a Combination Product06/01/2023
    2NDC:0031-9306-0216 in 1 BLISTER PACK; Type 0: Not a Combination Product06/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2023
    Labeler - Haleon US Holdings LLC (079944263)
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