Sodium Chloride

Dosage form: solution
Ingredients: SODIUM CHLORIDE 0.027mg in 3mL
Labeler: Nephron Pharmaceuticals Corporation
NDC Code: 0487-9301

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.

WARNINGS

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

DOSAGE AND ADMINISTRATION

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.

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 0487-9301-03 3 mL, 100 vials per carton

NDC 0487-9301-33 3 mL, 30 vials per carton/1 vial per foil pouch

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

1-800-443-4313

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display – Carton (100 count)

Principal Display – Carton (100 count)

Principal Display – Foil Pouch (30 individually wrapped vials)

SODIUM CHLORIDE 
isodium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0487-9301
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE0.027 mg  in 3 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:0487-9301-3330 POUCH (POUCH) in 1 CARTON
11 VIAL, SINGLE-USE (VIAL) in 1 POUCH
13 mL in 1 VIAL, SINGLE-USE
2NDC:0487-9301-03100 VIAL, SINGLE-USE (VIAL) in 1 CARTON
23 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other07/18/2002
Labeler - Nephron Pharmaceuticals Corporation (783905201)
Establishment
NameAddressID/FEIOperations
Nephron Pharmaceuticals Corporation783905201MANUFACTURE, ANALYSIS

Revised: 01/2012
 
Nephron Pharmaceuticals Corporation

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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