Label: SODIUM CHLORIDE-
SODIUM CHLORIDE-
- NHRIC Code(s): 0378-6997-89, 0378-6998-89
- Packager: Mylan Pharmaceuticals Inc.
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Premarket Notification
Drug Label Information
Updated October 20, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Sodium Chloride Inhalation Solution 3% 15 mL
PRODUCT CODE 0378-6997-89
Sodium Chloride
Inhalation Solution, USP
Sterile,
Preservative-free, Single-use Vials3% 15 mL
For Respiratory Therapy
Not for parenteral administration.
15 mL, 50 Vials
Sterile
Unit-Dose VialSodium Chloride Inhalation Solution, USP
3% 15 mLSterile, 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 mLInternal contents sterile. External surface of vial not sterile.
STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).
Rx only
CAUTION: Federal law restricts this device to sale by or on the order of a Physician.
Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 Manufactured by: The Ritedose Corporation, Columbia, SC 26203
TRC:6997:50C:R3
-
Sodium Chloride Inhalation Solution 10% 15 mL
PRODUCT CODE 0378-6998-89
Sodium Chloride
Inhalation Solution, USPSterile,
Preservative-free, Single-use Vials
10% 15 mLFor Respiratory Therapy
Not for parenteral administration.
15 mL, 50 Vials
Sterile
Unit-Dose VialSodium Chloride Inhalation Solution, USP
10% 15 mLSterile, 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 mLInternal contents sterile. External surface of vial not sterile.
STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).
Rx only
CAUTION: Federal law restricts this device to sale by or on the order of a Physician.
Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 Manufactured by: The Ritedose Corporation, Columbia, SC 26203
TRC:6998:50C:R3
-
INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
nebulizer (direct patient interface)Product Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:0378-6997 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 0.45 g in 15 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:0378-6997-89 50 in 1 CARTON 1 15 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K972778 10/15/2009 SODIUM CHLORIDE
nebulizer (direct patient interface)Product Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:0378-6998 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 1.5 g in 15 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:0378-6998-89 50 in 1 CARTON 1 15 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K972778 10/15/2009 Labeler - Mylan Pharmaceuticals Inc. (059295980)
