Q TUSSIN DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [PROFICIENT RX LP]

Q TUSSIN DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [PROFICIENT RX LP]
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NDC 63187-040-04
Set ID a3eff326-b2c6-4e2a-a424-912511433467
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredients (in each 5 mL = 1 tsp)

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 100 mg

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  • Purpose

    Cough suppressant

    Expectorant

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  • 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
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  • 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.

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  • Ask a doctor before use if you have

    cough that occurs with too much phlegm (mucus)
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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  • STOP USE

    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.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    do not take more than 6 doses in any 24-hour period
    this adult product is not intended for use in children under 12 years of age

    age (yr) 

    dose (tsp) 

    adults and children
    12 years and over 

    2 teaspoons
    every 4 hours 

    children under
    12 years 

    do not use

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  • Other information

    store at 15° to 30°C (59° to 86°F)
    dosage cup provided

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

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  • Inactive ingredients

    citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, liquid glucose, purified water, saccharin sodium, sodium benzoate

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  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 7/09 R4
    8281171  0855

    Repackaged by:
    Proficient Rx LP
    Thousand Oaks, CA 91320

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    Q TUSSIN DM 
    dextromethorphan hbr and guaifenesin syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-040(NDC:0603-0855)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color RED (clear, red) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63187-040-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 04/01/1995
    Labeler - Proficient Rx LP (079196022)
    Establishment
    Name Address ID/FEI Business Operations
    Proficient Rx LP 079502574 REPACK(63187-040) , RELABEL(63187-040)
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