País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)
PharmaCaribe
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.
Single-use plastic vials containing 4ml solution in cartons of 60 vials.
Exempt device
NEBUSAL- SODIUM CHLORIDE PHARMACARIBE ---------- NEBUSAL 3% DESCRIPTION SODIUM CHLORIDE INHALATION SOLUTION USP 3% 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 3% 4 ML PRODUCT CODE 50190-142-63 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 -142 ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRE NG TH STRE NG TH SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (CHLORIDE ION - UNII:Q32ZN48 6 9 8 , SODIUM CATION - UNII:LYR4M0 NH37) SODIUM CHLORIDE 120 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 -142-6 3 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 10 /26 /20 11 LABELER - PharmaCaribe (011702541) PharmaCaribe REGISTRANT - PharmaCaribe (011702541) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Pha rma Ca ribe 0 1170 254 Llegiu el document complet