Label: NEBUSAL-

  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated September 12, 2013

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  • DESCRIPTION

    Sodium Chloride Inhalation Solution USP 6% 4 mL


    For Respiratory Therapy

    Not for parenteral administration.

    4 mL, 60 Vials Sterile Unit-Dose Vial

    Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.


    Internal contents sterile. External surface of vial not sterile.

  • INDICATIONS AND USAGE

    The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.

  • INSTRUCTIONS FOR USE SECTION

    Hold vial gently twist and pull off top. Invert and squeeze to dispense prescribed volume into the nebulizer cup.

  • How Supplied

    Single-use plastic vials containing 4ml solution in cartons of 60 vials.

  • WARNINGS

    Not for injection or parenteral administration.

  • STORAGE

    Store at room temperature 15° to 30° C (50° to 86°F). Avoid excessive heat and protect from freezing.

  • Sodium Chloride Inhalation Solution USP 6% 4 mL

    PRODUCT CODE 50190-523-22

    Rx Only

    Manufactured by: Asept Pak, Inc. , Malone, NY 12953

    Distributed by: PharmaCaribe LLC. , Punta Gorda, FL 33950

    image description
  • INGREDIENTS AND APPEARANCE
    NEBUSAL 
    nebulizer (direct patient interface)
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:50190-523
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE240 mg  in 4 mL
    Product Characteristics
    number of times usable1
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:50190-523-2260 in 1 BOX
    14 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceCAF08/17/2010
    Labeler - PharmaCaribe (011702541)
    Registrant - PharmaCaribe (011702541)
    Establishment
    NameAddressID/FEIBusiness Operations
    PharmaCaribe011702541label
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