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QTussin (Qualitest Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
SOLUTION 1 BOTTLE, PLASTIC in 1 CARTON (0603-0857-54) > 118 mL in 1 BOTTLE, PLASTIC Label Information
SOLUTION 118 mL in 1 BOTTLE, PLASTIC (0603-0857-94) Label Information
SOLUTION 237 mL in 1 BOTTLE, PLASTIC (0603-0857-81) Label Information
SOLUTION 1 BOTTLE, PLASTIC in 1 CARTON (0603-0857-56) > 237 mL in 1 BOTTLE, PLASTIC Label Information
SOLUTION 473 mL in 1 BOTTLE, PLASTIC (0603-0857-58) Label Information

Complete QTussin Information

  • Active ingredient (in each 5 mL = 1 tsp)

    Guaifenesin, USP 100 mg


  • Purpose

    Expectorant


  • Use

    helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive


  • Warnings


  • 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

  • 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.


  • PREGNANCY OR BREAST FEEDING

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


  • Keep out of reach of children.

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


  • Directions

    • use an accurate measuring device to administer this medication 
    • 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 - 4 teaspoons
    every 4 hours 

    children under
    12 years 

    do not use


  • Other information

    • each tsp contains: sodium 2 mg
    • store at 15° to 30°C (59° to 86°F)

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


  • Inactive ingredients

    caramel color, FD&C red #40, flavor, glycerin, liquid glucose, purified water, saccharin sodium, sodium benzoate


  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 1/15 R9
    8073614  0857


  • PRINCIPAL DISPLAY PANEL

    Image of the label for Q-Tussin Chest Congestion 16 fl oz

  • INGREDIENTS AND APPEARANCE
    QTUSSIN 
    guaifenesin solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0857
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color ORANGE (clear, reddish-orange) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-0857-54 1 in 1 CARTON 10/01/1997 07/20/2018
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:0603-0857-56 1 in 1 CARTON 10/01/1997 07/20/2018
    2 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:0603-0857-58 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/1997 07/20/2018
    4 NDC:0603-0857-81 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/1997 07/20/2018
    5 NDC:0603-0857-94 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/1997 07/20/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/01/1997 07/20/2018
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE(0603-0857)