Pulmosal: Package Insert and Label Information

PULMOSAL- sodium chloride
PharmaCaribe

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

Pulmosal 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
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Established Pharmacological Class
Substance Pharmacological Class
Pulmosal Nebulizer (Direct Patient Interface)
PULMOSAL
Product Information
Product Type Item Code (Source) NHRIC:50190-740
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:50190-740-60 60 VIAL in 1 BOX contains a VIAL
1 4 mL in 1 VIAL This package is contained within the BOX (50190-740-60)
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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