Label: Q TUSSIN DM- dextromethorphan hydrobromide and guaifenesin syrup 

  • NDC Code(s): 0603-0855-54, 0603-0855-56, 0603-0855-58, 0603-0855-81, view more
    0603-0855-94
  • Packager: Qualitest Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • 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

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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 LABEL Item Code (Source) NDC:0603-0855
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    FD&C RED NO. 40  
    GLYCERIN  
    HIGH FRUCTOSE CORN SYRUP  
    DEXTROSE  
    WATER  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    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:0603-0855-54 1 in 1 CARTON
    1 118 mL in 1 BOTTLE, PLASTIC
    2 NDC:0603-0855-56 1 in 1 CARTON
    2 237 mL in 1 BOTTLE, PLASTIC
    3 NDC:0603-0855-58 473 mL in 1 BOTTLE, PLASTIC
    4 NDC:0603-0855-81 237 mL in 1 BOTTLE, PLASTIC
    5 NDC:0603-0855-94 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 04/01/1995
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE(0603-0855)
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