ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]

  • Home
  • ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]

ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]
PDF | XML
NDC 0031-8750-12, 0031-8750-18
Set ID 6a6f5da8-6433-4284-8df7-2d5b099b74dc
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART341
View All Sections
  • Active ingredients (in each 20 ml)

    Acetaminophen, USP 650 mg

    Dextromethorphan HBr, USP 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 9 AM to 5 PM EST at 1-800-762-4675

    Made in Canada

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

  • 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:

    1.
    Cough
    2.
    Sore Throat Pain
     
    Strong Cooling Liquid
    Non-Drowsy
     
    POWERFUL
    SORE THROAT
    Relief

    CF
    MAX

    For Ages 12 & Over

    4 FL OZ (118 ml)

    PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
  • 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 finalpart34104/10/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0031-8750) , LABEL(0031-8750) , MANUFACTURE(0031-8750) , PACK(0031-8750)
View All Sections

Related Drugs

Search DailyMed Drugs