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Sodium Chloride Inhalation Solution

Package insert / prescribing information
Dosage form: inhalation solution
Drug classes: Minerals and electrolytes, Miscellaneous respiratory agents

Medically reviewed by Drugs.com. Last updated on Sep 21, 2022.

Sodium Chloride Inhalation Solution 3% 15 mL

PRODUCT CODE 0378-6997-89

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

3% 15 mL

For Respiratory Therapy

Not for parenteral administration.

15 mL, 50 Vials
Sterile
Unit-Dose Vial

Sodium Chloride Inhalation Solution, USP
3% 15 mL

Sterile, 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).

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, USP

Sterile,
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, 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).

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

Established Pharmacological Class
Substance Pharmacological Class
Sodium Chloride Nebulizer (Direct Patient Interface)
Sodium Chloride Nebulizer (Direct Patient Interface)
SODIUM CHLORIDE
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NHRIC:0378-6997
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 0.45 g in 15 mL
Packaging
# Item Code Package Description
1 NHRIC:0378-6997-89 50 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
Premarket Notification K972778 10/15/2009
SODIUM CHLORIDE
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NHRIC:0378-6998
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 1.5 g in 15 mL
Packaging
# Item Code Package Description
1 NHRIC:0378-6998-89 50 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
Premarket Notification K972778 10/15/2009
Labeler - Mylan Pharmaceuticals Inc. (059295980)
Mylan Pharmaceuticals Inc.