Label: ROBITUSSIN CF- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid

  • NDC Code(s): 0031-8678-82
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 21, 2021

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

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL tsp)Purpose

    Dextromethorphan HBr, USP 10 mg

    Cough suppressant

    Guaifenesin, USP 100 mg

    Expectorant

    Pseudoephedrine HCl, USP 30 mg

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    temporarily relieves these symptoms occurring with a cold:
    nasal congestion
    cough due to minor throat and bronchial irritation
  • WARNINGS

    Warnings

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOl) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOl drug. If you do not know if your prescription drug contains an MAOl, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged prostate gland
    cough that occurs with too much phlegm (mucus)
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    When using this product do not use more than directed.

    Stop use and ask a doctor if

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

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than 4 doses in any 24-hour period
    agedose

    adults and children 12 years and over

    2 teaspoonfuls every 4 hours

    children 6 years to under 12 years

    1 teaspoonful every 4 hours

    under 6 years

    Do not use

  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, FD&C red no. 40, flavors, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help right away.

  • STORAGE AND HANDLING

    Other information

    store at 20-25°C (68-77°F)
    dosage cup provided
  • QUESTIONS

    MADE IN U.S.A.

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Wyeth®

    Robitussin®

    CF

    NASAL DECONGESTANT
    COUGH SUPPRESSANT
    EXPECTORANT

    CLEARS
    NASAL STUFFINESS
    CONTROLS COUGHS
    LOOSENS and RELIEVES
    CHEST CONGESTION

    COUGH FORMULA
    For Children and Adults

    4 FL OZ (118 mL)

    Principal Display Panel - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN CF 
    dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8678
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8678-821 in 1 CARTON07/01/2015
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only07/01/2015
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)