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

  • NDC Code(s): 0031-8702-13
  • 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 February 18, 2021

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

  • Active ingredients (in each 20 ml)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 200 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 20 ml contains: sodium 20 mg
    store at 20–25°C (68–77°F). Do not refrigerate.
  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum

  • 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 USA

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

    Children's
    Robitussin®

    AGES 4 & OVER

    Cough & Chest
    Congestion
    DM

    DEXTROMETHORPHAN HBr
    (Cough Suppressant)
    GUAIFENESIN (Expectorant)

    Alcohol-Free

    4 FL OZ (118 ml)

    Principal Display Panel - 118 ml Bottle Label
  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

    Children's
    Robitussin®

    FOR AGES 4 & OVER

    Cough & Chest
    Congestion
    DM

    DEXTROMETHORPHAN HBr
    (Cough Suppressant)
    GUAIFENESIN (Expectorant)

    Relieves:

    1.
    Chest Congestion/Mucus
    2.
    Cough

    Non-Drowsy

    BETTER
    TASTING!*
    Great Grape Taste

    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 and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8702
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    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)  
    Product Characteristics
    ColorPURPLE (purple) Score    
    ShapeSize
    FlavorGRAPE (grape) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8702-131 in 1 CARTON05/12/2020
    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 FINALpart34105/12/2020
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0031-8702) , LABEL(0031-8702) , MANUFACTURE(0031-8702) , PACK(0031-8702)