SODIUM CHLORIDE- SODIUM CHLORIDE- solution SODIUM CHLORIDE- solution

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Other medication manufactured, distributed, or labeled by Nephron Pharmaceuticals Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 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

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
nebulizer (direct patient interface)

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:0487-9003
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Chloride	120 mg  in 4 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:0487-9003-60	60 in 1 CARTON
1		4 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXEMPT DEVICE	CAF	04/20/2012

SODIUM CHLORIDE 
nebulizer (direct patient interface) solution

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:0487-9007
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Chloride	280 mg  in 4 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:0487-9007-60	60 in 1 CARTON
1		4 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXEMPT DEVICE	CAF	04/20/2012

SODIUM CHLORIDE 
nebulizer (direct patient interface) solution

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:0487-9010
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	Sodium Chloride	400 mg  in 4 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:0487-9010-60	60 in 1 CARTON
1		4 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXEMPT DEVICE	CAF	04/20/2012

Labeler - Nephron Pharmaceuticals Corporation (783905201)

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