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Ultra Tuss Safe (Ultra Seal Corporation)

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SYRUP 1 BOTTLE in 1 CARTON (42213-162-83) > 119 mL in 1 BOTTLE (42213-162-86) Label Information

Complete Ultra Tuss Safe Information

  • ACTIVE INGREDIENT

    ctive Ingredients (In 5 ml) Guaifenesin   100 mg Dextromethorphann HBr 10 mg …


  • PURPOSE

    Purpose: Expectorant, Antitussive (Anti Cough)


  • 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


  • 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)



  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children


  • 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


  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric Acid, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified water, Sodium Citrate, Sucralose


  • INGREDIENTS AND APPEARANCE
    ULTRA TUSS SAFE 
    guaifenesin dextromethorphan hbr syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42213-162
    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
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    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:42213-162-83 1 in 1 CARTON 06/19/2012
    1 NDC:42213-162-86 119 mL in 1 BOTTLE; Type 0: Not a Combination Product
    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(42213-162)