Label: PULMOSAL-

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

Drug Label Information

Updated November 20, 2013

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  • DESCRIPTION

    Pulmosal 7% (pH+) 4 mL
    Sodium Chloride Inhalation Solution 7%,
    Sterile, Preservative-free, Non-pyrogenic, pH 7.4

    Each Single-use vial contains 4ml sterile, preservative-free, non-pyrogenic Sodium Chloride Solution 7% for inhalation, pH 7.4

    FOR INHALATION ONLY

    NOT FOR INJECTION.

    Patent Pending
    RX Only

    60 x 4 mL Unit-Dose Vial

    NOT SUBSTITUTABLE with USP 7% Sodium Chloride

  • 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. Discard any unused solution of this single-use vial and any unused solution remaining in the nebulizer cup.

  • How Supplied

    Single-use plastic vials containing 4ml solution in cartons of 60 vials.
    NDC:50190-740-60

  • 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.

  • Pulmosal 7% (pH+) 4 mL

    PRODUCT CODE 50190-740-60

    Rx Only

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

    Manufactured For: PharmaCaribe, LLC , Punta Gorda, FL 33950

    image description
  • INGREDIENTS AND APPEARANCE
    PULMOSAL 
    nebulizer (direct patient interface)
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:50190-740
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE280 mg  in 4 mL
    Product Characteristics
    number of times usable1
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:50190-740-6060 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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