Label: ROBITUSSIN NIGHTTIME COUGH DM SOFT CHEWS- dextromethorphan hydrobromide, doxylamine succinate tablet, chewable

  • NDC Code(s): 0031-9311-20
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 29, 2024

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  • ACTIVE INGREDIENT

    Active ingredients (in each chewable tablet)

    Dextromethorphan equivalent to dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

  • PURPOSE

    Purposes

    Cough suppressant

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
      • runny nose
      • sneezing
      • itchy
      • watery eyes
      • itching of the nose or throat
    • controls the impulse to cough to help you sleep
  • WARNINGS

    Warnings

    Do not use

    • to sedate a child or to make a child sleepy
    • 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.

    Ask a doctor before use if you have

    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or is chronic such as occurs with smoking, asthma, or chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    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 hours, as needed

    children under 12 years

    do not use
  • STORAGE AND HANDLING

    Other information

    • each chewable tablet contains:potassium 10 mg, sodium 7 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, D&C red no. 30 aluminum lake, FD&C blue no. 1 aluminum lake, 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

    Nighttime Cough DM

    Soft CHEWS

    DEXTROMETHORPHAN HBr 15 mg
    (Cough Suppressant)

    DOXYLAMINE SUCCINATE 6.25 mg

    (Antihistamine)

    FAST relief ANYWHERE

    Cough, runny nose & sneezing

    UP TO 8HRCOUGH RELIEF

    20 CHEWABLE TABLETS

    Chew tablets completely before swallowing

    Berry flavor

    208797 Front Label

    Robitussin NT Cough DM Soft Chews 20 ct
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN NIGHTTIME COUGH DM SOFT CHEWS 
    dextromethorphan hydrobromide, doxylamine succinate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9311
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    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
    Colorpurple (darker purple speckles) Scoreno score
    ShapeROUNDSize21mm
    FlavorBERRYImprint Code R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-9311-2020 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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