RABOFEN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [A-S MEDICATION SOLUTIONS]

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RABOFEN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [A-S MEDICATION SOLUTIONS]
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NDC 50090-2657-0
Set ID 2ed83edb-d48e-4958-adc9-0c9092dd8ec5
Category HUMAN OTC DRUG LABEL
Packager A-S Medication Solutions
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 2 TSP (10 mL))Purposes
    Dextromethorphan HBr, USP 20 mgCough suppressant
    Guaifenesin, USP 200 mgExpectorant
  • 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 lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with too much phlegm (mucus).

    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 the 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
    • use enclosed dosing cup only. Do not use any other device.
    • this adult product is not intended for use in children under 12 years of age
    • TSP=teaspoonful
    adults and children 12 years and over2 TSP every 4 hours
    children under 12 yearsdo not use
  • Other information

    • each TSP (5 mL) contains: sodium 3 mg
    • store at 20°-25°C (68°-77°F). Do not refrigerate

    TAMPER-EVIDENT

    Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing

  • Inactive ingredients

    artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate

  • Questions or comments?

    (800)-616-2471

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive,
    Suite 233, Livonia, MI 48152

  • HOW SUPPLIED

    Product: 50090-2657

    NDC: 50090-2657-0 118 mL in a BOTTLE

  • Dextromethorphan Hydrobromide and GUAIFENESIN

    Label Image
  • INGREDIENTS AND APPEARANCE
    RABOFEN DM 
    guaifenesin and dextromethorphan hydrobromide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-2657(NDC:0904-0053)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Glycerin (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    Corn Syrup (UNII: 9G5L16BK6N)  
    PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorRED (Reddish-Pink) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-2657-0118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/01/2004
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-2657)
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