NEBUSAL- sodium chloride

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Available from:
PharmaCaribe
INN (International Name):
SODIUM CHLORIDE
Composition:
SODIUM CHLORIDE 240 mg in 4 mL
Therapeutic indications:
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.
Product summary:
Single-use plastic vials containing 4ml solution in cartons of 60 vials.
Authorization status:
Exempt device
Authorization number:
50190-523-22

NEBUSAL- sodium chloride

PharmaCaribe

----------

Nebusal 6%

DESCRIPTION

Sodium Chloride Inhalation Solution USP 6% 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 6% 4 mL

PRODUCT CODE 50190-523-22

Rx Only

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

Distributed by: PharmaCaribe LLC. , Punta Gorda, FL 33950

NEBUSAL

nebulizer (direct patient interface)

Product Information

Product T ype

MEDICAL DEVICE

Ite m Code (Source )

NHRIC:50 19 0 -523

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

SODIUM CHLORIDE

240 mg in 4 mL

Product Characteristics

numbe r of time s usable

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NHRIC:50 19 0 -523-22

6 0 in 1 BOX

1

4 mL in 1 VIAL

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

exempt device

0 8 /17/20 10

Labeler -

PharmaCaribe (011702541)

Registrant -

PharmaCaribe (011702541)

PharmaCaribe

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pha rma Ca ribe

0 1170 2541

la be l

Revised: 9/2013

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