Label: DEXTROSE 5% injection, solution

  • NDC Code(s): 85268-803-02, 85268-803-03, 85268-803-04, 85268-803-05, view more
    85268-803-06, 85268-803-07, 85268-803-08, 85268-803-09, 85268-803-10, 85268-803-11
  • Packager: Huaren Pharmaceutical Co., Ltd.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 24, 2025

If you are a consumer or patient please visit this version.

  • GLUCOSE (Dextrose) INJECTION, USP BAG

    Instructions for Glucose (Dextrose) Injection

    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.

  • INGREDIENTS

    This product is a sterilized aqueous solution of glucose.

    General Name: Glucose injection

    Molecular formula: C6H12O6·H2O

    Molecular weight: 198.17

    Auxiliary material name: Dilute hydrochloric acid

  • CHARACTER

    This product is colorless or almost colorless clear liquid.

  • INDICATIONS

    (1) Energy and fluid supplementation;It is used for underfeeding or massive fluid loss caused by various reasons (such as vomiting, diarrhea, etc.), total intravenous nutrition, and starvation ketosis.

    (2) Drug diluents.

  • SPECIFICATION

    (1)50ml:2.5g(2)50ml:5g(3)100ml:5g(4)100ml:10g(5)250ml:12.5g(6)250ml:25g(7)500ml:25g(8)500ml:50g(9)1000ml:50g(10)1000ml:100g

  • USAGE AND DOSAGE

    Intravenous infusion. Medication as prescribed.

  • ADVERSE REACTIONS

    1.Eating less, long-term simple supply of glucose solution can appear hypokalemia, hyponatremia and other electrolyte disorders. 2.Excessive infusion of this product may cause palpitations, arrhythmia, dyspnea, and even acute left heart failure in patients with cardiac insufficiency.

    3.Hypophosphatemia is easy to occur when combined with insulin without paying attention to phosphate supplement.

    4.Phlebitis may occur at the injection site.

    【Taboos】

    1. Uncontrolled diabetic ketoacidosis;

    2. Hyperglycemic nonketotic hyperosmolar state.

  • PRECAUTIONS

    1. Periodic paralysis, hypokalemia patients should be used with caution;

    2. Stress or glucocorticoid induced hyperglycemia should be used with caution; Patients with edema, cardiac and renal insufficiency and liver cirrhosis ascites are prone to water retention, and the infusion volume should be controlled. Drip velocity should be controlled especially in patients with cardiac insufficiency.

    3. Should be carefully checked before use, such as found leakage, solution turbidity, foreign bodies, etc., discarded.

    4. Should be used in sterile conditions.

  • MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN

    Too fast and too much fluid infusion may cause palpitation, arrhythmia and even acute left heart failure.

  • MEDICATION IN CHILDREN

    Too fast and too much fluid infusion may cause palpitation, arrhythmia and even acute left heart failure.

  • MEDICATION IN THE ELDERLY

    Too fast and too much fluid infusion may cause palpitation, arrhythmia and even acute left heart failure.

  • DRUG INTERACTIONS

    The experiment was not performed and no reliable reference was available.

  • DRUG OVERDOSE

    The experiment was not performed and no reliable reference was available.

  • PHARMACOLOGY AND TOXICOLOGY

    Glucose is an important nutrient component of the human body. Every 1 gram of glucose can produce 4 kilocalories of heat energy, so it is used to supplement heat.

  • PHARMACOKINETICS

    It can be converted into glycogen and fat for storage. The ability of a normal human body to utilize glucose is 6mg/kg per minute.

  • STORAGE

    Sealed storage

  • VALIDITY

    (1) The validity period of 250ml and 500ml products is 36 months.

    (2) The validity period of 50ml, 100ml and 1000ml products is 24 months.

  • PACKAGE

    1. Plastic infusion bag (non-PVC co-extrusion film, double hard pipe, easy to break apart, 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 break apart, double valve double plug, double layer sterile packaging). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag.

  • OTHER INFORMATION

    【Executive standard】

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

    【Pharmaceutical marketing authorization holder】

    Name: Huaren Pharmaceutical Co., Ltd. Registered Address: No. 187, Zhuzhou Road, Qingdao High-tech Park

    【Manufacturer】Enterprise Name: Huaren Pharmaceutical Co., Ltd. Production Address: No. 187, Zhuzhou Road, Qingdao High-tech Park Zip code: 266101 Telephone number: 0532-67709071 0532-67709728 Fax number: 0532-88702625

  • HEALTH CARE PROVIDER LETTER pg.1

    HEALTH CARE PROVIDER LETTER pg.1

  • HEALTH CARE PROVIDER LETTER pg.2

    HEALTH CARE PROVIDER LETTER pg.2

  • HEALTH CARE PROVIDER LETTER pg.3

    HEALTH CARE PROVIDER LETTER pg.3

  • PACKAGE LABEL– Dextrose 5% 50 mL Bag Label

     Dextrose 5% 50 mL Bag Label

  • PACKAGE LABEL– Dextrose 5% 100 mL Bag Label

    Dextrose 5% 100 mL Bag Label

  • PACKAGE LABEL-Dextrose 5% 500 mL Bag Label

    Dextrose 5% 500 mL Bag Label

  • PACKAGE LABEL-Dextrose 5% 250 mL Bag Label

     Dextrose 5% 250 mL Bag Label

  • PACKAGE LABEL-Dextrose 5% 1000 mL Bag Label

    Dextrose 5% 1000 mL Bag Label

  • INGREDIENTS AND APPEARANCE
    DEXTROSE 5% 
    dextrose 5% injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:85268-803
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) ANHYDROUS DEXTROSE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85268-803-0360 in 1 CASE03/07/2025
    1NDC:85268-803-0250 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:85268-803-0550 in 1 CASE03/07/2025
    2NDC:85268-803-04100 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:85268-803-0730 in 1 CASE03/07/2025
    3NDC:85268-803-06250 mL in 1 BAG; Type 0: Not a Combination Product
    4NDC:85268-803-0920 in 1 CASE03/07/2025
    4NDC:85268-803-08500 mL in 1 BAG; Type 0: Not a Combination Product
    5NDC:85268-803-1110 in 1 CASE03/07/2025
    5NDC:85268-803-101000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/07/2025
    Labeler - Huaren Pharmaceutical Co., Ltd. (547602854)