Label: DIMACOL- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

  • NDC Code(s): 0031-8729-01
  • Packager: Haleon US Holdings LLC
  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated April 23, 2024

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  • PRINCIPAL DISPLAY PANEL - Shipping Label

    1 Tote of 220 Gallons

    0031-8729-01

    GROSS: __________________

    TARE: ___________________

    NET: ____________________

    Dimacol

    FOR EXPORT

    CAUTION: FOR MANUFACTURING, PROCESSING, OR REPACKING ONLY
    STORE AT 20-25°C (68-77°F)

    Must be repackaged by

    LOT
    MFD

    Manufactured by:
    Fareva Richmond Inc.,
    Henrico, VA 23231 EUA

    Made in USA

    1

    Shipping Label
  • INGREDIENTS AND APPEARANCE
    DIMACOL 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:0031-8729
    Route of AdministrationNOT APPLICABLE
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8729-0175708 mL in 1 CONTAINER09/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only09/01/2015
    Labeler - Haleon US Holdings LLC (079944263)
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