NEBUSAL-

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)

متاح من:

PharmaCaribe

INN (الاسم الدولي):

SODIUM CHLORIDE

تركيب:

SODIUM CHLORIDE 240 mg in 4 mL

الخصائص العلاجية:

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.

ملخص المنتج:

Single-use plastic vials containing 4ml solution in cartons of 60 vials.

الوضع إذن:

Exempt device

خصائص المنتج

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
1
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
CAF
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