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

  • NDC Code(s): 0031-8762-12
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 14, 2023

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  • ACTIVE INGREDIENT

    Active ingredients (in each 10 ml)Purposes

    Dextromethorphan HBr, USP 15 mg

    Cough suppressant

    Doxylamine Succinate, USP 6.25 mg

    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:
    o
    runny nose
    o
    sneezing
    o
    itchy, watery eyes
    o
    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 are taking 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 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

    •
    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 1-800-762-4675

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 US

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

    Children's
    Robitussin®
    Honey
    For Ages 6+

    Nighttime
    Cough
    DM

    DEXTROMETHORPHAN HBR
    (COUGH SUPPRESSANT)
    DOXYLAMINE SUCCINATE (ANTIHISTAMINE)

    ALCOHOL
    FREE

    LONG-ACTING

     
    Relieves:
    1.
    Cough up to 8 hours
    2.
    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 finalpart34105/27/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0031-8762) , LABEL(0031-8762) , MANUFACTURE(0031-8762) , PACK(0031-8762)
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