Q-TUSSIN (GUAIFENESIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC]

Q-TUSSIN (GUAIFENESIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC]
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NDC 68788-9081-1
Set ID 36231ec1-97c0-4931-a689-ac74268a6bb7
Category HUMAN OTC DRUG LABEL
Packager Preferred Pharmaceuticals, Inc
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredient (in each 5 mL = 1 tsp)

    Guaifenesin, USP 100 mg

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  • Purpose

    Expectorant

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  • Use

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

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  • 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
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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 - 4 teaspoons
    every 4 hours 

    children under
    12 years 

    do not use

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  • Other information

    each tsp contains: sodium 2 mg
    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

    caramel color, FD&C red #40, flavor, glycerin, 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. 5/09 R7
    8273611  0857

    Relabeled By: Preferred Pharmaceuticals Inc.

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    Q-TUSSIN 
    guaifenesin solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9081(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)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    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:68788-9081-1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/1997
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/01/1997
    Labeler - Preferred Pharmaceuticals, Inc (791119022)
    Registrant - Preferred Pharmaceuticals, Inc (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals, Inc 791119022 RELABEL(68788-9081)
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