Sodium Chloride Solution: Package Insert and Label Information

SODIUM CHLORIDE SOLUTION- sodium chloride
PharmaCaribe

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.

Sodium Chloride Solution 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

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Established Pharmacological Class
Substance Pharmacological Class
Sodium Chloride Solution Nebulizer (Direct Patient Interface)
SODIUM CHLORIDE SOLUTION
Product Information
Product Type Item Code (Source) NHRIC:50190-141
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (CHLORIDE ION and SODIUM CATION) SODIUM CHLORIDE 280 mg in 4 mL
Product Characteristics
number of times usable 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:50190-141-23 60 VIAL in 1 BOX contains a VIAL
1 4 mL in 1 VIAL This package is contained within the BOX (50190-141-23)
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 Operations
PharmaCaribe 011702541 label

Revised: 11/2013 PharmaCaribe

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