ULTRA TUSS (GUAIFENESIN ) SYRUP [ULTRA SEAL CORPORATION]

ULTRA TUSS (GUAIFENESIN ) SYRUP [ULTRA SEAL CORPORATION]
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NDC 42213-160-93
Set ID f6f162ba-1c9b-436a-ba9e-fe49ac9a8e83
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

  • PURPOSE

    Purpose: Expectorant


  • INDICATIONS & USAGE

    Uses: temporarily:

    • helps loosen phlegm (mucus)

    • thin bronchial secretions to drain bronchial tubes, and make coughs more productive.

  • 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.

    Stop use and ask a doctor if:

    • symptoms do not improve

    • new symptoms occur

    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 health proffessional before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDEREN. 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 childern even if you do not notice any signs or smptoms.

  • 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, FD& C Red 40, Flavor, Glycerin, Methyl Paraben, Potassium Sorbate, Propyl Paraben, Purified water, Sodium Citrate, Sodium Saccharin

  • PRINCIPAL DISPLAY PANEL

    Ultra Tuss 16 oz labelUltra Tuss 16 oz labelUltra Tuss 16 oz label

  • INGREDIENTS AND APPEARANCE
    ULTRA TUSS  
    guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Colorred (cherry red) Score    
    ShapeSize
    FlavorCHERRY (sweet cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42213-160-93474 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2012
    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(42213-160)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004pack(42213-160)

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