Label: SODIUM CHLORIDE 0.9%- sodium chloride injection, solution

  • NDC Code(s): 85268-801-02, 85268-801-03
  • Packager: Huaren Pharmaceutical (Rizhao) Co., Ltd.
  • 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 March 7, 2025

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  • SODIUM CHLORIDE INJECTION, USP BAG
    Sodium Chloride Injection Instructions - Please read the instructions carefully and use under the guidance of a physician. Check carefully before use. Do not use if leakage is found, the drug ...
  • INGREDIENTS
    This product is an isotonic sterilizing aqueous solution of sodium chloride. Chemical Name: Sodium chloride - Molecular Formula: NaCl Molecular Weight: 58.44 Osmolality: 260~320 mOsmol/kg ...
  • CHARACTER
    This product is a colorless and clear liquid.
  • INDICATIONS
    It is used to regulate the balance of water and electrolytes in the body.
  • SPECIFICATION
    50ml: 0.45g; 100ml: 0.9g; 250ml: 2.25g; 500ml: 4.5g; 1000ml: 9g
  • DOSAGE AND USAGE
    Intravenous infusion, dosage according to the need of the disease.
  • ADVERSE REACTIONS
    Excessive and rapid infusion can cause water and sodium retention, edema, elevated blood pressure, rapid heart rate, chest tightness, dyspnea, and even acute left heart failure.
  • PRECAUTIONS
    Use with caution in the following cases: CD Edematous diseases, such as nephrotic syndrome, cirrhosis, ascites, congestive heart failure, acute left heart failure, brain edema, and idiopathic ...
  • MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN
    Not clear.
  • MEDICATION IN CHILDREN
    The amount and speed of fluid supplementation should be strictly controlled.
  • MEDICATION IN THE ELDERLY
    The amount and speed of fluid supplementation should be strictly controlled.
  • DRUG INTERACTIONS
    Should not be used with drugs with known incompatibility contraindications.
  • DRUG OVERDOSE
    For those with existing acidosis, a large amount of this product can cause hyperchloric acidosis.
  • PHARMACOLOGY AND TOXICOLOGY
    Sodium and chlorine are important electrolytes in the body, mainly in the extracellular fluid, and play a very important role in maintaining the normal blood and extracellular fluid volume and ...
  • PHARMACOKINETICS
    In the gastrointestinal tract, sodium is absorbed almost entirely through the active transport of intestinal mucosal cells. Sodium is excreted primarily by the kidneys.
  • PACKAGE
    Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve and double plug). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 10O0ml/ bag. Plastic infusion bag ...
  • VALIDITY
    The product of 50ml,100ml, and 1000ml specifications is valid for 24 months. The validity period of 250ml,500ml is 36 months.
  • STORAGE
    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
  • OTHER INFORMATION
    [EXECUTIVE STANDARD] Pharmacopoeia of the People's Republic of China (2020, Volume 11) [APPROVAL NUMBER] GuoYaoZhunZi: H20033208 (50ml: 0.45g) GuoYaoZhunZi: H20023682 (100ml ...
  • HEALTH CARE PROVIDER LETTER pg.1
    Pg1 DHCP
  • HEALTH CARE PROVIDER LETTER pg.2
    Pg2 DHCP
  • HEALTH CARE PROVIDER LETTER pg.3
    Pg3 DHCP
  • PACKAGE LABEL– 0.9% Sodium Chloride 1000 mL Bag Label
    SC 1000mL Bag
  • INGREDIENTS AND APPEARANCE
    Product Information