Sodium Chloride Injection (EUA)

Manufacturer
Huaren Pharmaceutical (Rizhao) Co., Ltd.
Effective date
2025-03-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:40:20

Label at a glance#

ProductSODIUM CHLORIDE 0.9%
Active ingredientSODIUM CHLORIDE
Label structure23 sections

Storage and handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] . Protect from freezing.

Label contents#

Full prescribing information#

SODIUM CHLORIDE INJECTION, USP BAG

SPL UNCLASSIFIED SECTION

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 liquid is unclear, or there are visible particles, do not use.

INGREDIENTS

DESCRIPTION SECTION

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

SPL UNCLASSIFIED SECTION

This product is a colorless and clear liquid.

INDICATIONS

INDICATIONS & USAGE SECTION

It is used to regulate the balance of water and electrolytes in the body.

SPECIFICATION

DESCRIPTION SECTION

50ml: 0.45g; 100ml: 0.9g; 250ml: 2.25g; 500ml: 4.5g; 1000ml: 9g

DOSAGE AND USAGE

DOSAGE & ADMINISTRATION SECTION

Intravenous infusion, dosage according to the need of the disease.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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

PRECAUTIONS SECTION

Use with caution in the following cases:

  1. CD Edematous diseases, such as nephrotic syndrome, cirrhosis, ascites, congestive heart failure, acute left heart failure, brain edema, and idiopathic edema
  2. Acute renal failure, oliguria stage, chronic renal failure, urine volume decreased, and poor response to diuretic drugs
  3. Hypertension
  4. Hypokalemia

Follow-up examination:

  1. CD Serum sodium, potassium, chlorine concentration
  2. Blood acid-base balance index
  3. Kidney function
  4. Blood pressure
  5. Cardiopulmonary function

MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN

PREGNANCY SECTION

Not clear.

MEDICATION IN CHILDREN

PEDIATRIC USE SECTION

The amount and speed of fluid supplementation should be strictly controlled.

MEDICATION IN THE ELDERLY

GERIATRIC USE SECTION

The amount and speed of fluid supplementation should be strictly controlled.

DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

Should not be used with drugs with known incompatibility contraindications.

DRUG OVERDOSE

OVERDOSAGE SECTION

For those with existing acidosis, a large amount of this product can cause hyperchloric acidosis.

PHARMACOLOGY AND TOXICOLOGY

CLINICAL PHARMACOLOGY SECTION

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 osmotic pressure of the human body. The normal serum sodium concentration is 135~145mmol/L, accounting for 92% of the plasma cation and 90% of the total osmotic pressure, so the amount of plasma sodium plays a decisive role in the osmotic pressure. The normal serum chlorine concentration is 98~106mmol/L, which is mainly regulated by the human body through the hypothalamus, posterior pituitary and kidney to maintain the stability of body fluid volume and osmotic pressure.

PHARMACOKINETICS

PHARMACOKINETICS SECTION

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

HOW SUPPLIED SECTION

  1. 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.
  2. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve double plug, double aseptic packaging). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag.

VALIDITY

SPL UNCLASSIFIED SECTION

  1. The product of 50ml,100ml, and 1000ml specifications is valid for 24 months.
  2. The validity period of 250ml,500ml is 36 months.

STORAGE

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

[EXECUTIVE STANDARD]

Pharmacopoeia of the People's Republic of China (2020, Volume 11)

[APPROVAL NUMBER]

GuoYaoZhunZi: H20033208 (50ml: 0.45g)

GuoYaoZhunZi: H20023682 (100ml: 0.9g)

GuoYaoZhunZi: H20023146 (250ml: 2.25g)

GuoYaoZhunZi: H20023145 (500ml: 4.5g)

GuoYaoZhunZi: H20023750 (1000ml: 9g)

[PHARMACEUTICAL MARKETING AUTHORIZATION HOLDER]

Name: Huaren Pharmaceutical Co., Ltd.

Registered Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China.

[MANUFACTURER]

Enterprise Name: Huaren Pharmaceutical Co., Ltd.

Production Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China. Zip code: 266101

Tel.: 400-0648885

Fax: 0532-67709071

Website: http//www.qdhuaren.com

Fax: 0532-88702625

HEALTH CARE PROVIDER LETTER pg.1

HEALTH CARE PROVIDER LETTER SECTION

Pg1 DHCPPg1 DHCP

HEALTH CARE PROVIDER LETTER pg.2

HEALTH CARE PROVIDER LETTER SECTION

Pg2 DHCPPg2 DHCP

HEALTH CARE PROVIDER LETTER pg.3

HEALTH CARE PROVIDER LETTER SECTION

Pg3 DHCPPg3 DHCP

PACKAGE LABEL– 0.9% Sodium Chloride 1000 mL Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SC 1000mL BagSC 1000mL Bag

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85268-801SODIUM CHLORIDE 0.9% (SODIUM CHLORIDE) INJECTION, SOLUTION [HUAREN PHARMACEUTICAL (RIZHAO) CO., LTD.]1Unmatched20250322_2fb7b6b2-460b-c39b-e063-6294a90aae61.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85268-80185268-801-02, 85268-801-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3699290e-ff30-fc74-e063-6294a90a422f2fb7b6b2-460b-c39b-e063-6294a90aae612025-06-02Adverse reactionsExact identifier
spl set id: 2fb7b6b2-460b-c39b-e063-6294a90aae61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.