ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [RICHMOND DIVISION OF WYETH]

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ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [RICHMOND DIVISION OF WYETH]
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NDC 0031-8739-12, 0031-8739-18, 0031-8739-42
Set ID f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each 20 ml)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    •
    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Warnings

    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.

    Ask a doctor before use if you have

    •
    cough that occurs with too much phlegm (mucus)
    •
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if 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

    20 ml every 4 hours

    children under 12 years

    do not use
  • Other information

    •
    each 20 ml contains: sodium 12 mg
    •
    store at 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, 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

    See
    New
    Dosing

    ADULT
    Robitussin®

    MAXIMUM STRENGTH

    Cough+Chest
    Congestion DM

    DEXTROMETHORPHAN HBr (Cough Suppressant)
    GUAIFENESIN (Expectorant)

    •
    Controls Cough
    •
    Relieves Chest Congestion
    •
    Thins & Loosens Mucus

    Non-Drowsy

    BETTER
    TASTING!
    Same Effective
    Cough Relief*

    DM
    MAX

    For Ages 12 & Over

    4 FL OZ (118 ml)

    Robitussin C and CC 118 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
    dextromethorphan hydrobromide, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8739
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8739-121 in 1 CARTON06/01/2016
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:0031-8739-181 in 1 CARTON06/01/2016
    2237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    3NDC:0031-8739-421 in 1 CARTON06/01/2016
    3355 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 finalpart34106/01/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0031-8739) , LABEL(0031-8739) , MANUFACTURE(0031-8739) , PACK(0031-8739)
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