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Sodium Chloride Inhalation Solution: Package Insert / Prescribing Info

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

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

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 3% 15mL Carton

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

Sodium Chloride Inhalation Solution 10% 15mL Carton
SODIUM CHLORIDE
nebulizer (direct patient interface)
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:0378-6997
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.45 g in 15 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:0378-6997-8950 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
Premarket NotificationK97277810/15/2009
SODIUM CHLORIDE
nebulizer (direct patient interface)
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:0378-6998
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE1.5 g in 15 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:0378-6998-8950 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
Premarket NotificationK97277810/15/2009
Labeler - Mylan Pharmaceuticals Inc. (059295980)

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