Label: ALFA 0.9% SODIUM CHLORIDE- sodium chloride injection, solution
- NDC Code(s): 72483-300-01, 72483-300-02, 72483-301-01, 72483-301-02, view more
- Packager: Laboratorios Alfa SRL
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Unapproved drug for use in drug shortage
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Drug Label Information
Updated February 13, 2025
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- Official Label (Printer Friendly)
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0.9% SODIUM CHLORIDE INJECTION, USP BAG
INTRAVENOUS USE - Sterile and Non pyrogenic - RX ONLY
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DESCRIPTION
0.9% SODIUM CHLORIDE ALFA, USP is a sterile, non-pyrogenic solution for fluid replenishment in single-dose containers for intravenous administration. Discard unused portions. It contains no ...
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INDICATIONS AND USAGE
Sodium chloride 0.9% Alfa, USP, for injection is an intravenous solution containing sodium chloride, indicated for parenteral replenishment of fluid and sodium chloride as required by the ...
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CONTRAINDICATIONS
Sodium chloride 0.9% Alfa, USP, for injection is contraindicated in patients with clinically significant hypersensitivity to any of its components. Contraindicated in patients with hypernatremia ...
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WARNINGS
0.9% Sodium chloride Alfa, USP, for injection, should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which ...
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PRECAUTIONS
General - Caution must be exercised in the administration of - 0.9% Sodium Chloride Alfa, USP solution for Injection, USP to patients receiving corticosteroids or corticotrophin. Do not ...
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DRUG INTERACTIONS
Caution must be exercised in the administration of - 0.9% Sodium Chloride Alfa, USP solution for Injection to patients receiving corticosteroids or corticotrophin ...
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CLINICAL PHARMACOLOGY
When administered intravenously, the solution provides a source of water and electrolytes. Solutions that provide combinations of hypotonic or isotonic concentrations of sodium chloride are ...
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ADVERSE REACTIONS
Reactions that may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the ...
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OVERDOSAGE
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (see - WARNINGS, PRECAUTIONS, and - ADVERSE REACTIONS).
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DOSAGE AND ADMINISTRATION
As directed by a doctor. Dosage is dependent upon the age, weight, and clinical condition of the patient, as well as laboratory determinations. Parenteral drug products should be inspected ...
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INSTRUCTIONS FOR USE
Check for leaks by squeezing the solution container firmly. If leaks are found, discard the solution, as sterility may be impaired. If supplemental medication is desired, follow the directions ...
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HOW SUPPLIED
Product CodeMaster case (Unit of Sale)Strength - Each - 100488NDC 72483-300-02 - Package of 12 - 0.9% ( 9,000 mg per 1000 mL) (9 mg per mL) NDC 72483-300-01 - 1000 ...
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STORAGE
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
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HEALTH CARE PROVIDER LETTER
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PACKAGE LABEL – 0.9% Sodium Chloride 1000 mL Bag Label
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PACKAGE LABEL – 0.9% Sodium Chloride 500 mL Bag Label
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PACKAGE LABEL – 0.9% Sodium Chloride 250 mL Bag Label
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PACKAGE LABEL – 0.9% Sodium Chloride 100 mL Bag Label
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INGREDIENTS AND APPEARANCEProduct Information