Label: CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin liquid

  • NDC Code(s): 0031-8715-10
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

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

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  • Active ingredients (in each 5 ml)

    Dextromethorphan HBr, USP 5 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

    measure only with dosing cup provided
    keep dosing cup with product
    ml = milliliter
    do not take more than 6 doses in any 24-hour period
    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 5 ml contains: sodium 3 mg
    store at 20-25°C (68-77°F). Do not refrigerate.
  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, natural flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • QUESTIONS

    Questions or comments?

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

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL

    NEW
    Dosing
    Information

    Children's
    Robitussin®
    NOW FOR AGES 4 & OVER

    Cough & Chest
    Congestion

    DM

    DEXTROMETHORPHAN HBr
    (Cough Suppressant)
    GUAIFENESIN (Expectorant)

    Relieves:

    ✓ Chest Congestion/Mucus
    ✓ Cough

    Non-Drowsy

     
    grape
    flavor

    4 FL OZ
    (118 ml)

    Principal Display Panel - 118 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8715
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLE (purple) Score    
    ShapeSize
    FlavorGRAPE (grape) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8715-101 in 1 CARTON07/01/2014
    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 finalpart34107/01/2014
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)