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

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

Drug Label Information

Updated April 24, 2024

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  • 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 useif 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 - Haleon US Holdings LLC (079944263)
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