Label: ULTRA TUSS - guaifenesin syrup

  • NDC Code(s): 42213-160-93
  • Packager: Ultra Seal Corporation
  • 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 06/12

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

  • ACTIVE INGREDIENT

    ctive Ingredients (In 5 ml) Guaifenesin   100 mg

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  • PURPOSE

    Purpose: Expectorant


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  • INDICATIONS & USAGE

    Uses: temporarily:
    •    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus,drain bronchial tubes, and make coughs more productive.

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  • WARNINGS


    Warnings:
    •    A persistent cough may be a sign of a serious condition.  If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
    Do not:
    •    Use more than the recommended dose.
    •    Do not take his product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
    Stop use and ask a doctor if:
    •    symptoms do not improve
    •    new symptoms occur
    •    redness or swelling is present
    •    nervousness, dizziness or sleeplessness occur
    •    symptoms do not improve within 7 days or are accompanied by 
    fever
    Ask a doctor before use if you have:
    •    heart disease
    •    high blood pressure
    •    thyroid disease
    •    diabetes
    •    difficulty in urination due to enlargement of the prostate gland
    •    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

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  • PRINCIPAL DISPLAY PANEL


    MM1


    Ultra Tuss 16oz label


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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • DOSAGE & ADMINISTRATION

    Directions:
    Adults and children 12 years of age and older
    •    Take 2 teaspoons (10 ml) every 4 hours as needed, do not exceed 12 
    teaspoons in 24 hours, or as directed by a doctor.
    •    Children 6-12 years, Take 1 teaspoon ( 5 ml) every 4 hours as needed, do not exceed 6 teaspoons in 24 hours, or as directed by a doctor.
    •    Children 2-6 years, Take 1/2 teaspoon ( 2.5 ml) every 4 hours as needed, do not exceed 3 teaspoons in 24 hours, or as directed by a doctor.
    •    Children under 2 years, consult a physician

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric Acid, FDC Red 40, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Purified water, Sodium Citrate, Sodium Saccharin

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  • INGREDIENTS AND APPEARANCE
    ULTRA TUSS  
    guaifenesin syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42213-160
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    PROPYLENE GLYCOL  
    SODIUM CITRATE  
    POTASSIUM SORBATE  
    PROPYLPARABEN  
    METHYLPARABEN  
    SACCHARIN  
    Product Characteristics
    Color red (cherry red) Score     
    Shape Size
    Flavor CHERRY (sweet cherry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42213-160-93 474 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/19/2012
    Labeler - Ultra Seal Corporation (085752004)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    ULTRAtab Laboratories, Inc. 151051757 manufacture
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