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Sodium Chloride by Cardinal Health

Medically reviewed on January 4, 2017

Dosage form: inhalant
Ingredients: SODIUM CHLORIDE 0.9mg in 100mL
Labeler: Cardinal Health
NDC Code: 55154-4358

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.

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

NDC 55154-4358-6 overbagged with 6 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).

Manufactured By:

Nephron Pharmaceuticals Corporation

Orlando, FL  32811

Or

Nephron Pharmaceuticals Corporation

West Columbia, SC 29172

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

Email: Customerservice@nephronpharm.com

Made in the USA

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L44920211216

L42450310515

10-09-06

PRINCIPAL DISPLAY PANEL

Sodium Chloride

Inhalation Solution, USP, 0.9%

6 x 3 ml Unit-Dose Vials

PRINCIPAL DISPLAY PANEL

Sodium Chloride

Inhalation Solution, USP, 0.9%

5 x 3 ml Unit-Dose Vials

Each in a foil pouch

SODIUM CHLORIDE 
sodium chloride inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-4358(NDC:0487-9301)
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE0.9 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:55154-4358-55 VIAL in 1 BAG
13 mL in 1 VIAL
2NDC:55154-4358-66 VIAL in 1 BAG
23 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/07/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-4358)

 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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