Label: ROBITUSSIN LONG-ACTING COUGH SOFT CHEWS- dextromethorphan hydrobromide tablet, chewable

  • NDC Code(s): 0031-9310-10, 0031-9310-20
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 13, 2024

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  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Dextromethorphan equivalent to dextromethorphan HBr 15 mg

  • PURPOSE

    Purpose

    Cough suppressant

  • INDICATIONS & USAGE

    Use

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • WARNINGS

    Warnings

    Do not useif 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.

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

    Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 4 doses (8 chewable tablets) in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age
    agedose

    adults and children

    12 years and over

    take 2 chewable tablets every 6 to 8 hours, as needed

    children under 12 years

    do not use
  • STORAGE AND HANDLING

    Other information

    • each chewable tablet contains:potassium 10 mg, sodium 6 mg
    • store at a controlled room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk

  • QUESTIONS

    Questions or comments?

    call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

  • Additional Information

    Do Not Use if seal under bottle cap imprinted with

    “SEALED for YOUR PROTECTION” is broken or missing.

    PARENTS:

    Learn about teen medicine abuse

    www.StopMedicineabuse.org

    Distributed by: Haleon, Warren, NJ 07059

    Trademarks are owned by or licensed to the Haleon group of companies.

    Pat. Info www.productpats.com

    ©2023 Haleon group of companies or its licensor.

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

  • PRINCIPAL DISPLAY PANEL

    NEW! ADULT HALEON

    Robitussin

    Long-Acting Cough

    Soft CHEWS

    DEXTROMETHORPHAN HBr 15 mg
    (Cough Suppressant)

    FAST relief ANYWHERE

    UP TO 8HRCOUGH RELIEF

    Chew tablets completely before swallowing

    Berry flavor

    10 CHEWABLE TABLETS

    208802 Front Label

    Robitussin Long-Acting Cough Soft Chews 10 ct
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN LONG-ACTING COUGH SOFT CHEWS 
    dextromethorphan hydrobromide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9310
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    COW MILK (UNII: 917J3173FT)  
    Product Characteristics
    Colorpink (darker pink speckles) Scoreno score
    ShapeROUNDSize21mm
    FlavorBERRYImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-9310-1010 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2024
    2NDC:0031-9310-2020 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/19/2024
    Labeler - Haleon US Holdings LLC (079944263)
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