Sodium Chloride

Manufacturer
Global Guard Services LLC | Shijianzhuang Pharmaceutical Co., No 4 Ltd
Effective date
2024-11-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:48:00

Label at a glance#

ProductSodium Chloride
Active ingredientSODIUM CHLORIDE
Label structure3 sections

Label contents#

Full prescribing information#

Sodium Chloride Carton and Labelling

HOW SUPPLIED SECTION

Sodium Chloride InjectionSodium Chloride Injection1000ml x 12 Bags

0.9% Sodium Chloride

Intravenous Infusion BP

Store below 25C

Handle with care

For human use only

Instructions For Use 0.9% Sodium Chloride Injection

INSTRUCTIONS FOR USE SECTION

Instructions For Use

0.9% Sodium Chloride Injection
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 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]
(1) Use with caution in the following cases:
① 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.
(2) Follow-up examination: ① Serum sodium, potassium, chlorine concentration; ② Blood
acid-base balance index; ③ Kidney function; ④ Blood pressure and cardiopulmonary
function.
[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 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]
In the gastrointestinal tract, sodium is absorbed almost entirely through the active transport
of intestinal mucosal cells. Sodium is excreted primarily by the kidneys.
[Storage] Sealed storage.
[Package]
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, 1000ml/ 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]
(1) The product of 50ml,100ml and 1000ml specifications is valid for 24 months.
(2) The validity period of 250ml,500ml is 36 months.
[Executive standard] Pharmacopoeia of the People's Republic of China (2020, Volume II)
[Pharmaceutical marketing authorization holder]
Name: Shijianzhuang No 4 Pharmaceutical Co., Ltd.
Registered Address: No. 518, East Huaian Road, High-tech Industrial Development Zone, Shijiazhuang, China
[Manufacturer]
Enterprise Name: Shijiazhuang No 4 Pharmaceutical Co., Ltd.
Production Address: No. 518, East Huaian Road, High-tech Industrial Development Zone, Shijiazhuang, China.
Zip code: 050035
Tel.: 0086-0311-67167144
Website:http//www.sjzsiyao.com

Sodium Chloride 1000ml Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Chloride InjectionSodium Chloride InjectionSodium Chloride InjectionSodium Chloride Injection1000ml/0.9%

Approval Number:

Non-PVC co-extruded film, double hard tube, easy to fold, double valve and
double plug

Sodium Chloride Injection

[Specification] 1000ml: 9g

Approximate osmolality

pH

Approx Millimoles per 1000ml

300Osm/kg

4.5 to 7

[Indications] It is used to regulate the balance of water and

electrolytes in the body.

[Dosage and Usage] Intravenous infusion, dosage according to the

need of the disease.

[Precautions] [Adverse reactions] See the instructions for details.
[Storage] Sealed storage. Store below 30C Do not freeze.

Check carefully before use. Do not use if leakage is found, the drug

liquid is unclear, or there are visible particles, do not use. Single
use. No antimicrobial preservatives. Discard any unused solution.
Keep out of reach of children.

Supplied by

Global Guard Services LLC Miami Fla

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84845-806-032024-12-06C16284748780-1289f7d6c-2123-4b20-e063-dadaa90ad71f25e50639-8490-87e2-e063-6294a90a8ef3

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84845-80684845-806-01, 84845-806-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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
25e50639-8491-87e2-e063-6294a90a8ef325e50639-8490-87e2-e063-6294a90a8ef32024-11-01Exact identifier
spl id: 25e50639-8491-87e2-e063-6294a90a8ef3
spl set id: 25e50639-8490-87e2-e063-6294a90a8ef3

Reported adverse events (FAERS/openFDA)#

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