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Sodium Chloride Inhalation Solution

Pronunciation

Dosage Form: inhalation solution

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.

3 mL, 100 Vials
Sterile
Unit-Dose Vial

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 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

Manufactured by: Catalent, Woodstock, IL 60098 Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505

DYM:6985:100C:R2

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.

5 mL, 100 Vials
Sterile
Unit-Dose Vial

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. 

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INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal 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

Manufactured by: Catalent, Woodstock, IL 60098 Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 

DYM:6986:100C:R2

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.

15 mL, 50 Vials
Sterile
Unit-Dose Vial

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 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

Manufactured by: Catalent, Woodstock, IL 60098 Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505

DYM:6987:50C:R2

Sodium Chloride Inhalation Solution 3% 15 mL

PRODUCT CODE 0378-6997-89

Sodium Chloride
Inhalation Solution, USP
Sterile, Non-pyrogenic,
Preservative-free, Single-use Vials

3% 15mL

For Respiratory Therapy

Not for parenteral administration.

15 mL, 50 Vials
Sterile
Unit-Dose Vial

Sodium Chloride Inhalation Solution, USP
3% 15 mL

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

INDICATIONS: Contents of these vials are for use in the induction of sputum production where specimen collection is indicated.

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 15 mL solutions supplied in cartons of 50 vials.

PRODUCT CODE 0378-6997-89 Sodium Chloride Inhalation Solution USP 3%, 15 mL
PRODUCT CODE 0378-6998-89 Sodium Chloride Inhalation Solution USP 10%, 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).

CAUTION: Federal law restricts this device to sale by or on the order of a Physician.

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

DYM:6997:50C:RD:R1

Sodium Chloride Inhalation Solution 10% 15 mL

PRODUCT CODE 0378-6998-89

Sodium Chloride
Inhalation Solution, USP

Sterile, Non-pyrogenic,
Preservative-free, Single-use Vials
10% 15 mL

For Respiratory Therapy

Not for parenteral administration.

15 mL, 50 Vials
Sterile
Unit-Dose Vial

Sodium Chloride Inhalation Solution, USP
10% 15 mL

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

INDICATIONS: Contents of these vials are for use in the induction of sputum production where specimen collection is indicated.

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 15 mL solutions supplied in cartons of 50 vials.

PRODUCT CODE 0378-6997-89 Sodium Chloride Inhalation Solution USP 3%, 15 mL
PRODUCT CODE 0378-6998-89 Sodium Chloride Inhalation Solution USP 10%, 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).

CAUTION: Federal law restricts this device to sale by or on the order of a Physician.

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

DYM:6998:50C:RD:R1

SODIUM CHLORIDE 
sodium chloride solution
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NDC:0378-6985
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 0.027 mg  in 3 mL
Packaging
# Item Code Package Description
1 NDC:0378-6985-01 100 VIAL (VIAL) in 1 CARTON
1 3 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/24/2010
SODIUM CHLORIDE 
sodium chloride solution
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NDC:0378-6986
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 0.045 mg  in 5 mL
Packaging
# Item Code Package Description
1 NDC:0378-6986-01 100 VIAL (VIAL) in 1 CARTON
1 5 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/24/2010
SODIUM CHLORIDE 
sodium chloride solution
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NDC:0378-6987
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 0.135 mg  in 15 mL
Packaging
# Item Code Package Description
1 NDC:0378-6987-89 50 VIAL (VIAL) in 1 CARTON
1 15 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/24/2010
SODIUM CHLORIDE 
sodium chloride solution
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NDC:0378-6997
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 0.45 mg  in 15 mL
Packaging
# Item Code Package Description
1 NDC:0378-6997-89 50 VIAL (VIAL) in 1 CARTON
1 15 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/24/2010
SODIUM CHLORIDE 
sodium chloride solution
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NDC:0378-6998
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 1.5 mg  in 15 mL
Packaging
# Item Code Package Description
1 NDC:0378-6998-89 50 VIAL (VIAL) in 1 CARTON
1 15 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/24/2010
Labeler - Mylan Pharmaceuticals Inc. (059295980)
Registrant - Mylan Pharmaceuticals Inc. (059295980)
Revised: 03/2010
 
Mylan Pharmaceuticals Inc.



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