SODIUM CHLORIDE- sodium chloride
Nephron Pharmaceuticals Corporation

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Sodium Chloride Inhalation Solution, USP 0.9%

Sodium Chloride Inhalation Solution, USP 0.9% 3 mL

NDC 0487-9301-33

Sodium Chloride
Inhalation Solution, USP 0.9%

Sterile, non-pyrogenic, preservative-free
single-use vials for respiratory therapy.

No bacteriostatic agent or other
preservative added.

MADE
IN THE
USA

For Respiratory Therapy
Not for parenteral administration.

nephron
pharmaceuticals
corporation
Orlando, FL 32811

30 × 3 mL Sterile Unit-Dose Vials, each in a foil pouch.

INDICATIONS: This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.

This device is not intended for parenteral use or for preparations intended for parenteral use.

WARNING: Not for injection or in preparations to be used for injection.

DIRECTIONS FOR USE: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.

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

HOW SUPPLIED: Sodium Chloride Inhalation Solution, USP 0.9% is supplied in single-use plastic vials in the following configurations:

NDC 0487-9301-03 3 mL, 100 vials per carton
NDC 0487-9301-33 3 mL, 30 vials per carton / 1 vial per foil pouch
NDC 0487-9301-02 3 mL, 30 vials per carton / 1 vial per foil pouch / robot ready
NDC 0487-9302-01 5 mL, 100 vials per carton
NDC 0487-9315-30 15 mL, 30 vials per carton

Internal contents sterile. External surface of vial not sterile.

STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).

Rx Only

Please Recycle

IC 426
Rev. 09-23-14

Sodium Chloride Inhalation Solution, USP 0.9% 3 mL

Sodium Chloride Inhalation Solution, USP 0.9% 5 mL

NDC 0487-9302-01

Sodium Chloride
Inhalation Solution, USP 0.9%

Sterile, non-pyrogenic, preservative-free
single-use vials for respiratory therapy.

No bacteriostatic agent or other preservative
added.

For Respiratory Therapy
Not for parenteral administration.

100 × 5 mL Sterile Unit-Dose Vials

Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811

INDICATIONS: This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.

This device is not intended for parenteral use or for preparations intended for parenteral use.

WARNING: Not for injection or in preparations to be used for injection.

DIRECTIONS FOR USE: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.

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

HOW SUPPLIED: Sodium Chloride Inhalation Solution, USP 0.9% is supplied in single-use plastic vials in the following configurations:

NDC 0487-9301-03 3 mL, 100 vials per carton
NDC 0487-9301-33 3 mL, 30 vials per carton / 1 vial per foil pouch
NDC 0487-9301-02 3 mL, 30 vials per carton / 1 vial per foil pouch / robot ready
NDC 0487-9302-01 5 mL, 100 vials per carton
NDC 0487-9315-30 15 mL, 30 vials per carton

Internal contents sterile. External surface of vial not sterile.

STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).

Rx Only

Please Recycle

IC 440
Rev. 09-23-14

Sodium Chloride Inhalation Solution, USP 0.9% 5 mL

Sodium Chloride Inhalation Solution, USP 0.9% 15 mL

NDC 0487-9315-30

Sodium Chloride
Inhalation Solution, USP 0.9%

Sterile, non-pyrogenic, preservative-free single-use vials for
respiratory therapy.

No bacteriostatic agent or other preservative added.

For Respiratory Therapy
Not for parenteral administration.

30 × 15 mL Sterile Unit-Dose Vials

Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811

MADE
IN THE
USA

INDICATIONS: This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.

This device is not intended for parenteral use or for preparations intended for parenteral use.

WARNING: Not for injection or in preparations to be used for injection.

DIRECTIONS FOR USE: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.

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

HOW SUPPLIED: Sodium Chloride Inhalation Solution, USP 0.9% is supplied in single-use plastic vials in the following packaging configurations:

NDC 0487-9301-03 3 mL, 100 vials per carton
NDC 0487-9301-33 3 mL, 30 vials per carton / 1 vial per foil pouch
NDC 0487-9301-02 3 mL, 30 vials per carton / 1 vial per foil pouch / robot ready
NDC 0487-9302-01 5 mL, 100 vials per carton
NDC 0487-9315-30 15 mL, 30 vials per carton

STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).

Internal contents sterile. External surface of vial not sterile.
Rx Only

IC 446
Rev. 08-27-14

Sodium Chloride Inhalation Solution, USP 0.9% 15 mL

SODIUM CHLORIDE
nebulizer (direct patient interface)

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:0487-9301
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Chloride	9 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:0487-9301-33	30 in 1 CARTON
1		1 in 1 POUCH
1		3 mL in 1 VIAL, SINGLE-USE
2	NHRIC:0487-9301-03	100 in 1 CARTON
2		3 mL in 1 VIAL, SINGLE-USE
3	NHRIC:0487-9301-02	1 in 1 BAG
3		1 in 1 POUCH
3		3 mL in 1 VIAL, SINGLE-USE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
EXEMPT DEVICE	CAF	06/25/2012

SODIUM CHLORIDE
nebulizer (direct patient interface)

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:0487-9302
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Chloride	9 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:0487-9302-01	100 in 1 CARTON
1		5 mL in 1 VIAL, SINGLE-USE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
EXEMPT DEVICE	CAF	06/25/2012

SODIUM CHLORIDE
nebulizer (direct patient interface)

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:0487-9315
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Chloride	9 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:0487-9315-30	30 in 1 CARTON
1		15 mL in 1 VIAL, SINGLE-USE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
EXEMPT DEVICE	CAF	02/09/2015

Labeler - Nephron Pharmaceuticals Corporation (783905201)

Name	Address	ID/FEI	Business Operations
Establishment
Nephron Pharmaceuticals Corporation		783905201	MANUFACTURE, ANALYSIS, PACK

Revised: 1/2015

Document Id: d4f4bb56-dc7d-4dfe-91b4-9ccf39a81d97

Set id: 6a8d9753-fa9a-4429-b0da-a999751c117f

Version: 3

Effective Time: 20150130

Nephron Pharmaceuticals Corporation