RABOFEN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [PREFERRED PHARMACEUTICALS INC.]

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RABOFEN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [PREFERRED PHARMACEUTICALS INC.]
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NDC 68788-0841-1
Set ID 88f0dd33-06ba-406f-b7b9-9b71fe69673f
Category HUMAN OTC DRUG LABEL
Packager Preferred Pharmaceuticals Inc.
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 mg

    Cough suppressant

    Guaifenesin, USP 200 mg

    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 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 over

    2 TSP every 4 hours

    children under 12 years

    do 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

    Relabeled By: Preferred Pharmaceuticals Inc.

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    NDC 68788-0841-1
    TAMPER-EVIDENT

    MAJOR ®
    PHARMACEUTICALS

    ROBAFEN™DM

    cough formula
    Cough Suppressant
    Expectorant

    *Compare to active ingredients of
    Robitussin ®Cough+Chest Congestion DM

    Dextromethorphan HBr, USP 20 mg and
    Guaifenesin, USP 200 mg per 10 mL

    •
    Alcohol free
    •
    Non-narcotic

    4 FL. OZ. (118 mL)

    Relabeled By: Preferred Pharmaceuticals Inc.

    Robafen DM
  • INGREDIENTS AND APPEARANCE
    RABOFEN DM 
    guaifenesin and dextromethorphan hydrobromide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0841(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:68788-0841-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/15/2018
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-0841)
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