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.

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

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

Not for injection or parenteral administration.

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

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

SODIUM CHLORIDE SOLUTION
nebulizer (direct patient interface)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

Labeler - PharmaCaribe (011702541)

Registrant - PharmaCaribe (011702541)

Name	Address	ID/FEI	Business Operations
Establishment
PharmaCaribe		011702541	label