Label: CHILDRENS ROBITUSSIN HONEY NIGHTTIME COUGH DM- dextromethorphan hbr, doxylamine succinate solution

  • NDC Code(s): 0031-8762-12
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 2, 2024

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  • Active ingredients (in each 10mL)

    Dextromethorphan HBr, USP 15 mg

    Doxylamine Succinate, USP 6.25 mg

  • 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 as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • 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

    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • do not take more than 4 doses in any 24-hour period
    agedose

    children under 6 years

    do not use

    children 6 to under 12 years

    10 mL every 6 hours

    adults and children 12 years and older

    20 mL every 6 hours
  • STORAGE AND HANDLING

    Other information

    • each 10 mL contains: sodium 10 mg
    • store at 20–25°C (68–77°F)
  • 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 1-800-245-1040

  • Additional Information

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

    Dist. by: Haleon, Warren, NJ 07059

    ©2024 Haleon or licensor.

    Trademarks owned or licensed by Haleon.

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

    Pat. Info www.productpats.com

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    Children's
    Robitussin
    Honey
    For Ages 6+

    Nighttime
    Cough
    DM

    DEXTROMETHORPHAN HBR
    (COUGH SUPPRESSANT)
    DOXYLAMINE SUCCINATE (ANTIHISTAMINE)

    ALCOHOL
    FREE

    LONG-ACTING

    • Relieves:
    • Cough up to 8hours
    • Runny nose

    Taste the
    Real Honey

    TRUE
    SOURCE
    CERTIFIED
    HONEY ✓

    4 FL OZ (118 mL)

    Childrens Robitussin honey NT cough DM 4 fl oz (118 ml)
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ROBITUSSIN HONEY NIGHTTIME COUGH DM 
    dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8762
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 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:0031-8762-121 in 1 CARTON05/27/2019
    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 DrugM01205/27/2019
    Labeler - Haleon US Holdings LLC (079944263)
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