SODIUM CHLORIDE inhalant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Cardinal Health 107, LLC

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 0.9 mg in 100 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

OTC DRUG

Therapeutic indications:

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

Product summary:

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. 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: [e-mail] Made in the USA Distributed By: Cardinal Health Dublin, OH 43017 L44920210519

Authorization status:

unapproved drug other

Summary of Product characteristics

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: [e-mail]
Made in the USA
Distributed By:
Cardinal Health
Dublin, OH 430