Label: ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT- acetaminophen, dextromethorphan hydrobromide liquid

  • NDC Code(s): 0031-8750-12, 0031-8750-18
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 2, 2024

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

  • Active ingredients (in each 20 mL)

    Acetaminophen, 650 mg

    Dextromethorphan HBr, 20 mg

  • Purposes

    Pain reliever/Fever reducer

    Cough suppressant

  • Uses

    • temporarily relieves these symptoms occurring with a cold or flu:
      • cough due to minor throat and bronchial irritation
      • minor aches and pains
      • sore throat pain
      • headache
    • temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 6 doses in any 24-hour period, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert:acetaminophen may cause severe skin reactions.
    Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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.
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if you have

    • liver disease
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking any other pain reliever/fever reducer

    When using this product do not use more than directed.

    Stop use and ask a doctor if

    • pain or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts. 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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
    • 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

    20 mL every 4 hours

    children under 12 years

    do not use

  • Other information

    • each 20 mL contains:sodium 13 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, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

  • SPL UNCLASSIFIED SECTION

    Dist. by: GSK CH, Warren, NJ 07059

    For most recent product information,

    visit www.robitussin.com

    Trademarks owned or licensed by GSK

    ©2022 GSK or licensor Made in Mexico

    000065356 Front Carton

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

    ADULT

    Robitussin

    MAXIMUM STRENGTH

    SEVERE
    Cough +
    Sore Throat

    ACETAMINOPHEN (Pain Reliever/Fever Reducer)
    DEXTROMETHORPHAN HBr (Cough Suppressant)

    Relieves:

    Cough

    Sore Throat Pain

    Strong Cooling Liquid
    Non-Drowsy

    POWERFUL
    SORE THROAT
    Relief

    CF
    MAX

    For Ages 12 & Over

    4 FL OZ (118 ml)

    Robitussin MS Severe C+ST 4 fl oz (118 ml)
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT 
    acetaminophen, dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8750
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 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)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8750-121 in 1 CARTON04/10/2017
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:0031-8750-181 in 1 CARTON04/10/2017
    2237 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 DrugM01204/10/2017
    Labeler - Haleon US Holdings LLC (079944263)