Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in the following: Size Container NDC 5 mL Glass ampules packed in carton of 25 each 65282-1505-1 10 mL Glass ampules packed in carton of 25 each 65282-1510-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Spectra Medical Devices, LLC Wilmington, MA 01887 (978) 657-0889 By: Huons Co., Ltd. 100 Bio valley-ro Jecheon-si Chungcheongbuk-do, 27159 Republic of Korea XX#### Rev. # MM/YY; Principal Display Panel - 5 mL Carton Label Rx only 25 Single-dose ampules Each single-dose ampule contains 5 mL NDC 65282-1505-1 0.9% Sodium Chloride Injection, USP Each mL contains sodium chloride, 9 mg in water for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. 0.308 mOsmol/mL. FOR USE AS A STERILE DILUENT Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature], PRESERVATIVE-FREE To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y MANUFACTURED FOR: SPECTRA MEDICAL DEVICES, LLC. WILMINGTON, MA. 01887 BY: HUONS. CO., LTD. Jecheon, Korea 27159 sodium_5_case; Principal Display Panel - 5 mL Ampule Label NDC 65282-1505-1 5 mL Ampule 0.9% Sodium Chloride Injection, USP 0.308 mOsmol/mL (calc) Rx only Single-dose FOR USE AS A STERILE DILUENT PRESERVATIVE-FREE Each mL contains sodium chloride, 9 mg. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. MANUFACTURED FOR: Spectra Medical Devices, LLC. Wilmington, MA 01887 By: Huons. Co., Ltd. Jecheon, Korea 27159 To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. LOT No.: XXX000 EXP.: YYYY/MM sodium_5_label; Principal Display Panel - 10 mL Carton Label Rx only 25 Single-dose ampules Each single-dose ampule contains 10 mL NDC 65282-1510-1 0.9% Sodium Chloride Injection, USP Each mL contains sodium chloride, 9 mg in water for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. 0.308 mOsmol/mL (calc). FOR USE AS A STERILE DILUENT For additional information, see package insert. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. PRESERVATIVE-FREE To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y MANUFACTURED FOR: SPECTRA MEDICAL DEVICES, LLC. WILMINGTON, MA.01887 BY : HUONS CO., LTD. Jecheon, Korea 27159 sodium_10_case; Principal Display Panel - 10 mL Ampule Label NDC 62582-1510-1 10 mL Ampule 0.9 % Sodium Chloride Injection, USP 0.308 mOsmol/mL (calc) Rx only Single-dose FOR USE AS A STERILE DILUENT PRESERVATIVE-FREE Each mL contains sodium chloride, 9 mg. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. MANUFACTURED FOR: Spectra Medical Devices, LLC Wilmington, MA 01887 By: Huons Co., Ltd. Jecheon, Korea 27159 To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. LOT No.: XX0000 EXP.: YYYY/MM sodium_10_label
- HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in the following: Size Container NDC 5 mL Glass ampules packed in carton of 25 each 65282-1505-1 10 mL Glass ampules packed in carton of 25 each 65282-1510-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Spectra Medical Devices, LLC Wilmington, MA 01887 (978) 657-0889 By: Huons Co., Ltd. 100 Bio valley-ro Jecheon-si Chungcheongbuk-do, 27159 Republic of Korea XX#### Rev. # MM/YY
- Principal Display Panel - 5 mL Carton Label Rx only 25 Single-dose ampules Each single-dose ampule contains 5 mL NDC 65282-1505-1 0.9% Sodium Chloride Injection, USP Each mL contains sodium chloride, 9 mg in water for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. 0.308 mOsmol/mL. FOR USE AS A STERILE DILUENT Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature], PRESERVATIVE-FREE To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y MANUFACTURED FOR: SPECTRA MEDICAL DEVICES, LLC. WILMINGTON, MA. 01887 BY: HUONS. CO., LTD. Jecheon, Korea 27159 sodium_5_case
- Principal Display Panel - 5 mL Ampule Label NDC 65282-1505-1 5 mL Ampule 0.9% Sodium Chloride Injection, USP 0.308 mOsmol/mL (calc) Rx only Single-dose FOR USE AS A STERILE DILUENT PRESERVATIVE-FREE Each mL contains sodium chloride, 9 mg. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. MANUFACTURED FOR: Spectra Medical Devices, LLC. Wilmington, MA 01887 By: Huons. Co., Ltd. Jecheon, Korea 27159 To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. LOT No.: XXX000 EXP.: YYYY/MM sodium_5_label
- Principal Display Panel - 10 mL Carton Label Rx only 25 Single-dose ampules Each single-dose ampule contains 10 mL NDC 65282-1510-1 0.9% Sodium Chloride Injection, USP Each mL contains sodium chloride, 9 mg in water for injection. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. 0.308 mOsmol/mL (calc). FOR USE AS A STERILE DILUENT For additional information, see package insert. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. PRESERVATIVE-FREE To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y MANUFACTURED FOR: SPECTRA MEDICAL DEVICES, LLC. WILMINGTON, MA.01887 BY : HUONS CO., LTD. Jecheon, Korea 27159 sodium_10_case
- Principal Display Panel - 10 mL Ampule Label NDC 62582-1510-1 10 mL Ampule 0.9 % Sodium Chloride Injection, USP 0.308 mOsmol/mL (calc) Rx only Single-dose FOR USE AS A STERILE DILUENT PRESERVATIVE-FREE Each mL contains sodium chloride, 9 mg. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. MANUFACTURED FOR: Spectra Medical Devices, LLC Wilmington, MA 01887 By: Huons Co., Ltd. Jecheon, Korea 27159 To open ampules, using gauze, place thumb and forefinger on color line, break at constriction. Product Code: XXXX-Y Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. LOT No.: XX0000 EXP.: YYYY/MM sodium_10_label
Overview
This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH range is 4.5 to 7.0. The glass ampules made up of Type I glass are used as a primary container for the drug product. Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.
Indications & Usage
INDICATION AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Dosage & Administration
The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .
Warnings & Precautions
No warnings available yet.
Adverse Reactions
Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
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