Label: RABOFEN DM- guaifenesin and dextromethorphan hydrobromide solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 18, 2020

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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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