SODIUM CHLORIDE inhalant

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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).

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

Distributed By:

Cardinal Health

Dublin, OH 43017

L44920210318

10-09-06

PRINCIPAL DISPLAY PANEL

Sodium Chloride

Inhalation Solution, USP, 0.9%

5 x 3 ml Unit-Dose Vials

Each in a foil pouch

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride inhalant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-4358(NDC:0487-9301)
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	0.9 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-4358-5	5 in 1 BAG	06/07/2011
1		3 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
Unapproved drug other		06/07/2011

Labeler - Cardinal Health (603638201)