Label: CHILDRENS ROBITUSSIN COUGH LONG-ACTING- dextromethorphan hydrobromide liquid

  • NDC Code(s): 0031-8694-12
  • 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 October 29, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • Active ingredient (in each 10 ml)

    Dextromethorphan HBr, USP 15 mg

  • Purpose

    Cough suppressant

  • Use

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

  • 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

    1.
    cough that occurs with too much phlegm (mucus)
    2.
    cough that lasts or is chronic such as occurs with smoking, asthma, 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.

  • Directions

    1.
    measure only with dosing cup provided
    2.
    keep dosing cup with product
    3.
    ml = milliliter
    4.
    do not take more than 4 doses in any 24-hour period
    agedose

    children under 4 years

    do not use

    children 4 to under 6 years

    5 ml every 6 - 8 hours

    children 6 to
    under 12 years

    10 ml
    every 6 to 8 hours

    adults and children
    12 years and older

    20 ml
    every 6 to 8 hours

  • Other information

    1.
    each 10 ml contains: sodium 11 mg
    2.
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate

  • Questions or comments?

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

    Distributed by:
    Pfizer, Madison, NJ 07940 USA

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

  • PRINCIPAL DISPLAY PANEL

    NEW
    Dosing
    Information

    Children's
    Robitussin®
    NOW FOR AGES 4 & OVER

    Cough

    Long-Acting

    DEXTROMETHORPHAN HBr (Cough Suppressant)

    Relieves:

    ✓ Cough Up to 8 Hours

    Alcohol-Free

    fruit
    punch
    flavor

    4 FL OZ
    (118 ml)

    Principal Display Panel  - 118 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ROBITUSSIN COUGH LONG-ACTING 
    dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8694
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorRED (bright red) Score    
    ShapeSize
    FlavorFRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8694-121 in 1 CARTON07/01/2015
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2004
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)