SODIUM CHLORIDE- sodium chloride  
Mylan Pharmaceuticals Inc.

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Sodium Chloride Inhalation Solution 0.9% 3 mL

PRODUCT CODE 0378-6985-01

Sodium Chloride
Inhalation Solution, USP
0.9% 3 mL

For Respiratory Therapy

Not for Parenteral Administration.

100 x 3 mL
Sterile Unit-Dose Vials

Sodium Chloride Inhalation Solution, USP
0.9% 3 mL

Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy. No bacteriostatic agent or other preservative added.

INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal irrigation or lavage.

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: Single-use plastic vials containing 3 mL or 5 mL solutions supplied in cartons of 100 vials and 15 mL solution supplied in cartons of 50 vials.

PRODUCT CODE 0378-6985-01 Sodium Chloride Inhalation Solution, USP 0.9%, 3 mL
PRODUCT CODE 0378-6986-01 Sodium Chloride Inhalation Solution, USP 0.9%, 5 mL
PRODUCT CODE 0378-6987-89 Sodium Chloride Inhalation Solution, USP 0.9%, 15 mL

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

For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Manufactured by: The Ritedose Corporation Columbia, SC 29203

TRC:6985:100C:R3

Sodium Chloride Inhalation Solution 0.9% 3mL Carton

Sodium Chloride Inhalation Solution 0.9% 5 mL

PRODUCT CODE 0378-6986-01

Sodium Chloride
Inhalation Solution, USP
0.9% 5 mL

For Respiratory Therapy

Not for Parenteral Administration.

100 x 5 mL
Sterile Unit-Dose Vials

Sodium Chloride Inhalation Solution, USP
0.9% 5 mL

Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy. No bacteriostatic agent or other preservative added. 

INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal irrigation or lavage. 

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: Single-use plastic vials containing 3 mL or 5 mL solutions supplied in cartons of 100 vials and 15 mL solution supplied in cartons of 50 vials. 

PRODUCT CODE 0378-6985-01 Sodium Chloride Inhalation Solution, USP 0.9%, 3 mL
PRODUCT CODE 0378-6986-01 Sodium Chloride Inhalation Solution, USP 0.9%, 5 mL
PRODUCT CODE 0378-6987-89 Sodium Chloride Inhalation Solution, USP 0.9%, 15 mL

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

For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Manufactured by: The Ritedose Corporation Columbia, SC 29203

TRC:6986:100C:R3

Sodium Chloride Inhalation Solution 0.9% 5mL Carton

Sodium Chloride Inhalation Solution 0.9% 15 mL

PRODUCT CODE 0378-6987-89

Sodium Chloride
Inhalation Solution, USP
0.9% 15 mL

For Respiratory Therapy

Not for parenteral administration.

50 x 15 mL
Sterile Unit-Dose Vials

Sodium Chloride Inhalation Solution, USP
0.9% 15 mL

Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy. No bacteriostatic agent or other preservative added.

INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal irrigation or lavage.

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: Single-use plastic vials containing 3 mL or 5 mL solutions supplied in cartons of 100 vials and 15 mL solution supplied in cartons of 50 vials.

PRODUCT CODE 0378-6985-01 Sodium Chloride Inhalation Solution, USP 0.9%, 3 mL
PRODUCT CODE 0378-6986-01 Sodium Chloride Inhalation Solution, USP 0.9%, 5 mL
PRODUCT CODE 0378-6987-89 Sodium Chloride Inhalation Solution, USP 0.9%, 15 mL

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

For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 Manufactured by: The Ritedose Corporation Columbia, SC 29203

TRC:6987:50C:R3

Sodium Chloride Inhalation Solution 0.9% 15mL Carton
SODIUM CHLORIDE 
nebulizer (direct patient interface)
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:0378-6985
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.027 g  in 3 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:0378-6985-01100 in 1 CARTON
13 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Exempt deviceCCQ10/12/2009
SODIUM CHLORIDE 
nebulizer (direct patient interface)
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:0378-6986
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.045 g  in 5 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:0378-6986-01100 in 1 CARTON
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Exempt deviceCCQ10/12/2009
SODIUM CHLORIDE 
nebulizer (direct patient interface)
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:0378-6987
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.135 g  in 15 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:0378-6987-8950 in 1 CARTON
115 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Exempt deviceCCQ10/12/2009
Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 12/2016
Document Id: 4d16fad7-5731-4a9f-9cb1-ca7a6cb738df
Set id: d4ec61e7-c506-43bb-88cf-e75e4dd64e1b
Version: 4
Effective Time: 20161202
 
Mylan Pharmaceuticals Inc.