SODIUM CHLORIDE SOLUTION-

Sodium Chloride Solution by

Drug Labeling and Warnings

Sodium Chloride Solution by is a Other medication manufactured, distributed, or labeled by PharmaCaribe. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Sodium Chloride Inhalation Solution USP 7% 4 mL

For Respiratory Therapy

Not for parenteral administration.

4 mL, 60 Vials Sterile Unit-Dose Vial

Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.

Internal contents sterile. External surface of vial not sterile.

INDICATIONS AND USAGE

The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.

INSTRUCTIONS FOR USE SECTION

Hold vial gently twist and pull off top. Invert and squeeze to dispense prescribed volume into the nebulizer cup.

How Supplied

Single-use plastic vials containing 4ml solution in cartons of 60 vials.

WARNINGS

Not for injection or parenteral administration.

STORAGE

Store at room temperature 15° to 30° C (50° to 86°F). Avoid excessive heat and protect from freezing.

Sodium Chloride Inhalation Solution USP 7% 4 mL

PRODUCT CODE 50190-141-23

Rx Only

Manufactured by: Asept Pak, Inc. , Malone, NY 12953

Exclusively Distributed by: Cystic Fibrosis Services, Inc. , Bethesda, MD 20814

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE SOLUTION 
nebulizer (direct patient interface)

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:50190-141

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	280 mg  in 4 mL

Product Characteristics
number of times usable	1

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:50190-141-23	60 in 1 BOX
1		4 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	CAF	08/17/2010

Labeler - PharmaCaribe (011702541)

Registrant - PharmaCaribe (011702541)

Establishment
Name	Address	ID/FEI	Business Operations
PharmaCaribe		011702541	label