Label: SODIUM CHLORIDE-
SODIUM CHLORIDE- solution
SODIUM CHLORIDE- solution

  • NHRIC Code(s): 0487-9003-60, 0487-9007-60, 0487-9010-60
  • Packager: Nephron Pharmaceuticals Corporation
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated September 17, 2014

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  • Sodium Chloride Inhalation Solution, USP 3%

    NDC 0487-9003-60

    Sodium Chloride
    Inhalation Solution, USP 3%

    Sterile, Preservative-free, Non-pyrogenic
    FOR RESPIRATORY THERAPY
    NOT FOR INJECTION

    Rx Only
    60 x 4 mL Sterile Unit-Dose Vials

    Manufactured By:
    nephron
    pharmaceuticals
    corporation
    Orlando, FL 32811

    For Customer Service,
    Call 1-800-443-4313

    Each single-use vial contains 4ml sterile, preservative-free, non-pyrogenic Sodium Chloride Solution 3% for respiratory therapy.

    INDICATIONS: To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

    WARNING: Not for injection or parenteral administration.

    DIRECTIONS FOR USE: Hold vial gently twist and pull off top. Invert and squeeze to dispense prescribed volume.

    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# 0487-9003-60

    STORAGE: Store at room temperature 15° to 30° C (59° to 86° F). Avoid excessive heat and protect from freezing.

    CAUTION: Rx Only

    Please Recycle

    IC 441
    Rev. 12-20-11

    Sodium Chloride Inhalation Solution, USP 3%
  • Sodium Chloride Inhalation Solution, USP 7%

    NDC 0487-9007-60

    Sodium Chloride
    Inhalation Solution, USP 7%

    Sterile, Preservative-free, Non-pyrogenic
    FOR RESPIRATORY THERAPY
    NOT FOR INJECTION

    Rx Only
    60 x 4 mL Sterile Unit-Dose Vials

    Manufactured By:
    nephron
    pharmaceuticals
    corporation
    Orlando, FL 32811

    For Customer Service,
    Call 1-800-443-4313

    Each single-use vial contains 4ml sterile, preservative-free, non-pyrogenic Sodium Chloride Solution 7% for respiratory therapy.

    INDICATIONS: To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

    WARNING: Not for injection or parenteral administration.

    DIRECTIONS FOR USE: Hold vial gently twist and pull off top. Invert and squeeze to dispense prescribed volume.

    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# 0487-9007-60

    STORAGE: Store at room temperature 15° to 30° C (59° to 86° F). Avoid excessive heat and protect from freezing.

    CAUTION: Rx Only

    Please Recycle

    IC 442
    Rev. 12-20-11

    Sodium Chloride Inhalation Solution, USP 7%
  • Sodium Chloride Inhalation Solution, USP 10%

    NDC 0487-9010-60

    Sodium Chloride
    Inhalation Solution, USP 10%

    Sterile, Preservative-free, Non-pyrogenic
    FOR RESPIRATORY THERAPY
    NOT FOR INJECTION

    Rx Only
    60 x 4 mL Sterile Unit-Dose Vials

    Manufactured By:
    nephron
    pharmaceuticals
    corporation
    Orlando, FL 32811

    For Customer Service,
    Call 1-800-443-4313

    Each single-use vial contains 4ml sterile, preservative-free, non-pyrogenic Sodium Chloride Solution 10% for respiratory therapy.

    INDICATIONS: To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

    WARNING: Not for injection or parenteral administration.

    DIRECTIONS FOR USE: Hold vial gently twist and pull off top. Invert and squeeze to dispense prescribed volume.

    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# 0487-9010-60

    STORAGE: Store at room temperature 15° to 30° C (59° to 86° F). Avoid excessive heat and protect from freezing.

    CAUTION: Rx Only

    Please Recycle

    IC 443
    Rev. 12-20-11

    Sodium Chloride Inhalation Solution, USP 10%
  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    nebulizer (direct patient interface)
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:0487-9003
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride120 mg  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0487-9003-6060 in 1 CARTON
    14 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXEMPT DEVICECAF04/20/2012
    SODIUM CHLORIDE 
    nebulizer (direct patient interface) solution
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:0487-9007
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride280 mg  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0487-9007-6060 in 1 CARTON
    14 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXEMPT DEVICECAF04/20/2012
    SODIUM CHLORIDE 
    nebulizer (direct patient interface) solution
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:0487-9010
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride400 mg  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0487-9010-6060 in 1 CARTON
    14 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXEMPT DEVICECAF04/20/2012
    Labeler - Nephron Pharmaceuticals Corporation (783905201)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nephron Pharmaceuticals Corporation783905201MANUFACTURE, ANALYSIS, PACK
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