Label: CHILDRENS ROBITUSSIN COUGH AND COLD CF- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

  • NDC Code(s): 0031-8716-12
  • 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.

  • Active ingredients (in each 10 ml)

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 100 mg

    Phenylephrine HCl, USP 5 mg

  • Purposes

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    1.
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    2.
    temporarily relieves these symptoms occurring with a cold:
    1.
    nasal congestion
    2.
    cough due to minor throat and bronchial irritation
  • 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.
    heart disease
    2.
    high blood pressure
    3.
    thyroid disease
    4.
    diabetes
    5.
    trouble urinating due to an enlarged prostate gland
    6.
    cough that occurs with too much phlegm (mucus)
    7.
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

    When using this product do not use more than directed.

    Stop use and ask a doctor if

    1.
    you get nervous, dizzy, or sleepless
    2.
    symptoms do not get better within 7 days or are accompanied by fever
    3.
    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 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

  • Other information

    1.
    each 10 ml contains: sodium 7 mg
    2.
    store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

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

  • 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 & Cold

    CF

    DEXTROMETHORPHAN HBr
    (Cough Suppressant)
    GUAIFENESIN (Expectorant)
    PHENYLEPHRINE HCl (Nasal Decongestant)

    Relieves:

    Cough
    Chest Congestion/Mucus
    Stuffy Nose

    Non-Drowsy

    grape
    flavor

    4 FL OZ
    (118 ml)

    PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ROBITUSSIN COUGH AND COLD CF 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8716
    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) GUAIFENESIN50 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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
    ColorRED (clear red) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8716-121 in 1 CARTON09/01/2009
    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 finalpart34109/01/2009
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)