Label: ROBITUSSIN CHEST CONGESTION- guaifenesin liquid

  • NDC Code(s): 0031-8748-04
  • Packager: Wyeth Consumer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated December 4, 2019

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    4 FL OZ (118mL)

    Robitussin®

    (GUAIFENESIN SYRUP, USP)

    EXPECTORANT

    DIRECTIONS: Follow dosage below:
    Do Not Exceed Recommended Dosage.

    ADULT DOSE (and children 12 years and
    over): 2 - 4 teaspoonfuls every 4 hours.

    CHILD DOSE
    6 yrs. to under 12 yrs.:
    1 - 2 teaspoonfuls every 4 hours.

    Children under 6 yrs.:
    Do not use.

    TAMPER-EVIDENT BOTTLE CAP.
    IF BREAKABLE RING IS
    SEPARATED, DO NOT USE.

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Robitussin®

    (GUAIFENESIN
    SYRUP, USP)

    EXPECTORANT

    • LOOSENS and RELIEVES
      CHEST CONGESTION

    ALCOHOL-FREE
    COUGH FORMULA
    For Children and Adults

    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
  • PRINCIPAL DISPLAY PANEL - Leaflet

    PRINCIPAL DISPLAY PANEL - Leaflet
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN CHEST CONGESTION 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8748
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8748-041 in 1 CARTON09/09/2013
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXPORT ONLY09/21/2004
    Labeler - Wyeth Consumer Healthcare LLC (828831730)
    Registrant - Pfizer Inc (113480771)