SODIUM CHLORIDE- sodium chloride inhalant 
Cardinal Health 107, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Sodium Chloride Inhalation Solution, USP 0.9%
FOR RESPIRATORY THERAPY
3 ml Sterile Unit Dose Vials

OTC - ACTIVE INGREDIENT

Sodium Chloride, USP
0.9% (0.027 mg per 1 mL)

OTC - PURPOSE

Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy.
No bacteriostatic agent or other preservative added.

INDICATIONS AND USAGE

Intended for use in respiratory therapy or for tracheal or lavage. This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.

WARNINGS

Not for injection or in preparations to be used for injection.

This device is not for parenteral use or for preparations intended for parenteral use.

CAUTION: Contents are sterile in the unopened, undamaged package.

DOSAGE AND ADMINISTRATION

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.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

RX ONLY

INACTIVE INGREDIENT

Water for Injection, USP

HOW SUPPLIED

Sodium Chloride Inhalation Solution, 0.9% is supplied in single-use plastic vials in the following configurations.

NDC 55154-4358-5 overbagged with 5 x 3 mL vial per bag

Internal contents sterile. External surface of vial not sterile.

Storage and Handling

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Nephron Pharmaceuticals Corporation

West Columbia, SC 29172

For Customer Service, Call 1-800-443-4313

Email: Customerservice@nephronpharm.com

Made in the USA

Distributed By:

Cardinal Health

Dublin, OH 43017

L44920210519

PRINCIPAL DISPLAY PANEL

Sodium Chloride

Inhalation Solution, USP, 0.9%

5 x 3 ml Unit-Dose Vials

Each in a foil pouch

bag label
SODIUM CHLORIDE 
sodium chloride inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-4358(NDC:0487-9301)
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.9 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-4358-55 in 1 BAG06/07/201107/31/2023
13 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/07/201107/31/2023
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 12/2022
 
Cardinal Health 107, LLC