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NEBUSAL ()
[PharmaCaribe]


Category DEA Schedule Marketing Status
MEDICAL DEVICE Exempt device
Drug Label Sections

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

image description
NEBUSAL 
nebulizer (direct patient interface)
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:50190-523
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE240 mg  in 4 mL
Product Characteristics
number of times usable1
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:50190-523-2260 in 1 BOX
14 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceCAF08/17/2010
Labeler - PharmaCaribe (011702541)
Registrant - PharmaCaribe (011702541)
Establishment
NameAddressID/FEIBusiness Operations
PharmaCaribe011702541label

Revised: 9/2013
 
PharmaCaribe

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