Label: CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin solution

  • NDC Code(s): 0031-8760-12
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 26, 2024

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  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 100 mg

  • Purposes

    Cough suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses

    •
    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • WARNINGS

    Warnings

    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.

    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, chronic bronchitis, or emphysema

    Stop use and ask a doctor 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.

    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 6 doses in any 24-hour period
    •
    measure only with dosing cup provided
    •
    keep dosing cup with product
    •
    mL = milliliter
    agedose

    children under 4 years

    do not use

    children 4 to under 6 years

    5 mL every 4 hours

    children 6 to under 12 years

    10 mL every 4 hours

    adults and children 12 years and over

    20 mL every 4 hours
  • STORAGE AND HANDLING

    Other information

    •
    each 10 mL contains: sodium 11 mg
    •
    store at 20-25°C (68-77°F). Do not refrigerate.
  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

  • QUESTIONS

    Questions or comments?

    call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

  • Additional information

    Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

    Distributed by: Haleon, Warren, NJ 07059

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

    Trademarks owned or licensed by Haleon.

    ©2024 Haleon or licensor.

    Made in Canada

    Should be 18 or older to purchase

    PARENTS:

    Learn about teen medicine abuse

    www.stopMedicineAbuse.org

  • PRINCIPAL DISPLAY PANEL

    Children's

    Robitussin

    Honey

    For Ages 4+

    Cough & Chest
    Congestion

    DM

    DEXTROMETHORPHAN HBr
    (Cough Suppressant)
    GUAIFENESIN (Expectorant)

    Relieves:
    ✓ Chest congestion
    ✓ Mucus
    ✓ Cough

    Taste the
    Real Honey

    TRUE
    SOURCE
    CERTIFIED
    HONEY✓

    4 FL OZ (118 mL)

    62000000207923 Front Carton

    Children's Robitussin Honey C CC DM 4 fl ozs
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8760
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    HONEY (UNII: Y9H1V576FH)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8760-121 in 1 CARTON06/25/2018
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/25/2018
    Labeler - Haleon US Holdings LLC (079944263)
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