Label: ULTRA TUSS DM - guaifenesin and dextromethorphan hydrobromide syrup

  • NDC Code(s): 42213-161-93
  • 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 Dextromethorphann HBr 10 mg …

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  • PURPOSE

    Purpose: Expectorant, Antitussive (Anti Cough)


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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.
    •    restores free breathing
    •    suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

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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.
    •    Give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.
    •    Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.
    •    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 MAOI drug. If you do not know if your prescription 
    drug contains an MAOI, consult a doctor or pharmacist before 
    taking this product
    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
    •    cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
    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 DM 16 oz 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, Propylene Glycol, Purified water, Sodium Citrate, Sodium Saccharin

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  • INGREDIENTS AND APPEARANCE
    ULTRA TUSS DM 
    guaifenesin dextromethorphan hbr syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42213-161
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    FD&C RED NO. 40  
    SODIUM CITRATE  
    SACCHARIN SODIUM ANHYDROUS  
    PROPYLPARABEN  
    METHYLPARABEN  
    POTASSIUM SORBATE  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (sweet cherry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42213-161-93 474 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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