Label: ASCORBIC ACID- ascorbic acid injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 18, 2018

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  • SPL UNCLASSIFIED SECTION

    FOR INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS USE.


    CONTAINS NO PRESERVATIVES.

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  • DESCRIPTION

    Ascorbic Acid (vitamin C) is a water-soluble vitamin. It occurs as a white or slightly yellow crystal or powder with a light acidic taste. It is an antiscorbutic product. On exposure to air and light it gradually darkens. In the dry state it is reasonably stable in air, but in solution it rapidly oxidizes. Ascorbic Acid is freely soluble in water; sparingly soluble in alcohol; insoluble in chloroform, ether, and benzene.

    The chemical name of Ascorbic Acid is L-ascorbic acid. The molecular formula is C6H806 and the molecular weight is 176.13. The structural formula is as follows:

    Structural formula ascorbic acid

    Ascorbic Acid injection is a clear, colorless to slightly yellow sterile solution of Ascorbic Acid in Water for Injection, for intravenous, intramuscular or subcutaneous use. Each mL contains: Ascorbic Acid 500 mg, Disodium Edetate 0.25 mg, in Water for Injection q.s.. pH (range 5.5 to 7.0) adjusted with Sodium Bicarbonate and Sodium Hydroxide. Contains no preservatives.

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  • CLINICAL PHARMACOLOGY

    In humans, an exogenous source of ascorbic acid is required for collagen formulation and tissue repair. Ascorbic acid is reversibly oxidized to dehydroascorbic acid in the body. These two forms of the vitamin are believed to be important in oxidation-reduction reactions. The vitamin is involved in tyrosine metabolism, conversion of folic acid to folinic acid, carbohydrate metabolism, synthesis of lipids and proteins, iron metabolism, resistance to infections, and cellular respiration.

    Ascorbic acid deficiency results in scurvy. Collagenous structures are primarily affected, lesions develop in bones and blood vessels. Administration of ascorbic acid completely reverses the symptoms of ascorbic acid deficiency.

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  • INDICATIONS & USAGE

    Ascorbic acid is recommended for the prevention and treatment of scurvy. Its parenteral administration is desirable for patients with an acute deficiency or for those whose absorption of orally ingested ascorbic acid is uncertain.


    Symptoms of mild deficiency may include faulty bone and tooth development, gingivitis, bleeding gums, and loosened teeth. Febril states, chronic illness, and infection (pneumonia, whooping cough, tuberculosis, diphtheria, sinusitis, rheumatic fever, etc.) increases the need for ascorbic acid. Hemovascular disorders, burns, delayed fracture and wound healing are indications for an increase in the daily intake.

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  • CONTRAINDICATIONS

    There are no contraindications to the administration of ascorbic acid

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  • WARNINGS

    Diabetics, patients prone to recurrent renal calculi, those undergoing stool occult blood tests and those on sodium restricted diets or anticoagulant therapy should not take excessive doses of ascorbic acid over an extended period of time.

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  • PRECAUTIONS

    General Precautions: Too-rapid intravenous injection is to be avoided.

    Laboratory Tests: Diabetics taking more than 500 mg of ascorbic acid daily may obtain false reading of the urinary glucose test. No exogenous ascorbic acid should be ingested for 48 to 72 hours before amine dependent stool occult blood tests are conducted because possible false negative results may occur.


    Drug Interactions: Limited evidence suggests that ascorbic acid may influence the intensity and duration of action of bishydroxycoumarin.


    Usage in Pregnancy : Pregnancy Category C


    Animal reproduction studies have not been conducted with Ascorbic Acid Injection. It is also not known whether Ascorbic Acid Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ascorbic Acid Injection should be given to a pregnant woman only if clearly needed.


    Nursing Mothers: Caution should be exercised when Ascorbic Acid Injection is administered to a nursing woman.

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  • ADVERSE REACTIONS

    Transient mild soreness may occur at the site of intramuscular or subcutaneous injection. Too-rapid intravenous administration of the solution may cause temporary faintness or dizziness.

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  • DOSAGE & ADMINISTRATION

    Ascorbic acid is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered intramuscularly, intravenously or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration, which is the preferred parenteral route.


    For intravenous injection, dilution into a large volume parenteral such as Normal Saline or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.


    The average protective dose of ascorbic acid for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 gram daily are recommended. However, as much as 6 grams have been administered parenterally to normal adults without evidence of toxicity.


    To enhance wound-healing, doses of 300 to 500 mg daily for a week to ten days, both preoperatively and postoperatively, are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 grams are recommended. In other conditions in which the need for ascorbic acid is increased, three to five times the daily optimum allowances appear to be adequate.

    WARNING


    PRESSURE MAY DEVELOP WITHIN THE VIAL UPON STORAGE.


    Exercise care when withdrawing and/or relieve pressure by first inserting sterile empty syringe into vial thus allowing pressure to equilibrate.


    When using dispensing vials use aseptic technique. Dispense entire contents in aliquots under a laminar flow hood without delay or within 4 hours after entry or discard remaining content after first withdrawal. Prepare stoppers with a suitable antiseptic solution. Do not use unless solution is clear and seal is intact.


    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

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  • HOW SUPPLIED

    Ascorbic Acid for Injection, USP (500 mg/mL)

    NDC 71414-115-01
    50 mL Sterile Dispensing Vial, individually packaged
    RX only


    PROTECT FROM LIGHT.
    STORE IN CARTON UNTIL TIME OF USE:
    Store between 2° to 8° C (36° to 46° F).


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  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    FLON LABORATORIES LLC

    Elkhorn, NE 68022 U.S.A
    www.flonlabs.com

    115PI

    Rev.0517

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  • PRINCIPAL DISPLAY PANEL

    NDC 71414-115-01 50mL


    Ascorbic
    Acid
    Injection, USP
    500 mg/mL


    For Intravenous, Intramuscular
    or Subcutaneous Use


    Rx only Vial

    Each mL contains: Absorbic Acid 500 mg, Disodium Edetate 0.25 mg,
    in Water for Injection q.s.. pH (range 5.5 to 7.0)
    adjusted with Sodium Bicarbonate and Sodium Hydroxide.


    Contains no preservatives.


    USUAL ADULT DOSAGE: See package insert for full prescribing information.


    WARNING: Use aseptic techniques. Dispense entire contents in aliquots
    under a laminar flow hood without delay or within 4 hours after entry, or
    discard remaining contents after first withdrawal. Prepare stoppers with a
    suitable antiseptic solution.
    Do not use unless solution is clear and seal is intact.

    STORE BETWEEN 2° TO 8°C (36° TO 46°F).


    Store in carton until time of use.


    PROTECT FROM LIGHT.


    PRESSURE MAY DEVELOP UPON STORAGE. EXCERCISE CARE
    WHEN WITHDRAWING.


    Manufactured for:
    FLON Laboratories LLC
    Elkhorn, NE 68022 U.S.A.
    www.flonlabs.com
    Rev: 05/17

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    ASCORBIC ACID 
    ascorbic acid injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71772-115
    Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 500 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.25 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71772-115-01 1 in 1 CARTON 10/06/2017
    1 50 mL in 1 VIAL, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/06/2017
    Labeler - Fisiopharma SRL (441067444)
    Establishment
    Name Address ID/FEI Business Operations
    Fisiopharma SRL 441067444 manufacture(71772-115)
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