ULTRA TUSS SAFE (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]

ULTRA TUSS SAFE (GUAIFENESIN DEXTROMETHORPHAN HBR) SYRUP [ULTRA SEAL CORPORATION]
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NDC 42213-162-83, 42213-162-86
Set ID b82c4e24-040e-461f-bb5a-9827d0461842
Category HUMAN OTC DRUG LABEL
Packager Ultra Seal Corporation
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active 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)

    • thin bronchial secretions to 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:

    Do not use:

    • 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.

    • more than the recommended dose.

    Stop use and ask a doctor if:

    • 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. These could be signs of a serious condition.

    Ask a doctor before use if you have:

    • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center Right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions:

    Do not exceed 6 doses in any 24 hour period.

    Adults and children 12 years of age and older: Take 2 teaspoons (10 ml) every 4 hours as needed, or as directed by a doctor.

    Children 6-12 years: Take 1 teaspoon ( 5 ml) every 4 hours as needed, or as directed by a doctor.

    Not to be used for children under 6 years of age.

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    ultra tuss safe 4 oz boxultra tuss safe 4 oz box

  • INGREDIENTS AND APPEARANCE
    ULTRA TUSS SAFE 
    guaifenesin dextromethorphan hbr syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-162
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (sweet cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42213-162-831 in 1 CARTON06/19/2012
    1NDC:42213-162-86119 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/19/2012
    Labeler - Ultra Seal Corporation (085752004)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab Laboratories, Inc.151051757manufacture(42213-162)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(42213-162)