PULMOSAL- sodium chloride  
PharmaCaribe

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Pulmosal 7% (pH+)

DESCRIPTION

Pulmosal 7% (pH+) 4 mL
Sodium Chloride Inhalation Solution 7%,
Sterile, Preservative-free, Non-pyrogenic, pH 7.4

Each Single-use vial contains 4ml sterile, preservative-free, non-pyrogenic Sodium Chloride Solution 7% for inhalation, pH 7.4

FOR INHALATION ONLY

NOT FOR INJECTION.

Patent Pending
RX Only

60 x 4 mL Unit-Dose Vial

NOT SUBSTITUTABLE with USP 7% Sodium Chloride

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. Discard any unused solution of this single-use vial and any unused solution remaining in the nebulizer cup.

How Supplied

Single-use plastic vials containing 4ml solution in cartons of 60 vials.
NDC:50190-740-60

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.

Pulmosal 7% (pH+) 4 mL

PRODUCT CODE 50190-740-60

Rx Only

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

Manufactured For: PharmaCaribe, LLC , Punta Gorda, FL 33950

image description
PULMOSAL 
nebulizer (direct patient interface)
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:50190-740
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE280 mg  in 4 mL
Product Characteristics
number of times usable1
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:50190-740-6060 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: 11/2013
Document Id: 44a6936d-2929-4170-9af2-1ec30d06e8ff
Set id: 8cd1575e-264e-4625-93e5-3dd8c5491bc2
Version: 1
Effective Time: 20131120
 
PharmaCaribe