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.
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
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| Unapproved drug other | 03/24/2010 | ||
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| Unapproved drug other | 03/24/2010 | ||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 03/24/2010 | ||
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| 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) |
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