Label: ROBITUSSIN PEAK COLD MULTI-SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

  • NDC Code(s): 0031-8742-14, 0031-8742-20
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 12, 2024

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  • Active ingredients (in each 10 ml)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 200 mg

    Phenylephrine HCl, USP 10 mg

  • Purposes

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occurring with a cold:
      • nasal congestion
      • cough due to minor throat and bronchial irritation
  • Warnings

    Do not useif 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

    • 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

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

    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.

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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
    • this adult product is not intended for use in children under 12 years of age
    agedose

    adults and children 12 years and over

    10 ml every 4 hours

    children under 12 years

    do not use

  • Other information

    • each 10 ml contains:sodium 6 mg
    • store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, 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

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL

    ADULT

    Robitussin®

    PEAK COLD

    Multi-Symptom
    Cold

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

    Relieves:

    • Cough
    • Nasal Congestion
    • Mucus

    Non-Drowsy CF

    For Ages 12 & Over

    4 FL OZ
    (118 ml)

    Robitussin Peak Cold MS C 4 fl oz
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN PEAK COLD MULTI-SYMPTOM COLD 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8742
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (clear red liquid) Score    
    ShapeSize
    FlavorBERRY (berry-citrus flavor) , CITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8742-141 in 1 CARTON06/12/2011
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0031-8742-201 in 1 CARTON06/12/2011
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/12/2011
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)