Label: MAGNESIUM CHLORIDE- magnesium chloride injection 

  • Label RSS
  • NDC Code(s): 67457-134-50
  • Packager: Mylan Institutional LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 03/13

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  • DESCRIPTION

    Magnesium Chloride Injection is a sterile solution of Magnesium Chloride Hexahydrate in Water for Injection q.s. Each mL contains Magnesium Chloride Hexahydrate 200 mg, Sodium Chloride 9 mg, Benzyl Alcohol 1% as a preservative, Water for Injection, q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Total osmolarity equivalent to 2.951 mOsm/mL.

    Contains 1.97 mEq of Mg++ and Cl- per mL.

    The structural formula is MgCl2•6H2O

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  • ACTIONS

    Magnesium is the second most plentiful cation within cellular fluids. It is an important activator of many enzyme systems and deficits are accompanied by a variety of functional disturbances.

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  • INDICATIONS

    As an electrolyte replenisher in magnesium deficiencies.

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  • CONTRAINDICATIONS

    Magnesium Chloride Injection should not be administered if there is renal impairment, marked myocardial disease or to comatose patients.

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  • WARNING

    Do not use if a precipitate is present.

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  • PRECAUTIONS

    The usual precautions for parenteral administration should be observed. Administer with caution if flushing and sweating occurs. A preparation of a calcium salt should be readily available for intravenous injection to counteract potential serious signs of magnesium intoxication. As long as deep tendon reflexes are active it is probable that the patient will not develop respiratory paralysis. Respiration and blood pressure should be carefully observed during and after administration of Magnesium Chloride Injection.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category C

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

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  • ADVERSE REACTIONS

    Flushing, sweating, sharply lowered blood pressure,hypothermia, stupor and ultimately respiratory depression.

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  • DOSAGE AND ADMINISTRATION

    For intravenous infusion: 4 grams in 250 mL of 5%Dextrose Injection, at a rate not exceeding 3 mL per minute. Serum magnesium levels should serve as a guide to continued dosage.

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  • USUAL DOSAGE RANGE

    1 to 40 grams daily.

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

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  • HOW SUPPLIED

    Magnesium Chloride Injection 200 mg/mL (20% w/v).

    NDC 67457-134-50
    50 mL Multiple-Dose Vial. Individually boxed.

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled
    Room Temperature.]

    Manufactured for:
    Mylan Institutional LLC
    Rockford, IL 61103

    Manufactured by:
    Mylan Institutional
    Galway, Ireland

    0546L104
    REVISED FEBRUARY 2013
    MI:MAGNIJ:R2

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  •   

    PRINCIPAL DISPLAY PANEL - 200 mg/mL

    NDC 67457-134-50     50 mL

    Magnesium
    Chloride
    Injection

    200 mg/mL
    (20% w/v)

    2.951 mOsm/mL

    For Intravenous Use After
    Dilution

    Rx only Multiple-Dose Vial

    Manufactured for:
    Mylan Institutional LLC
    Rockford, IL 61103 U.S.A.

    Manufactured by:
    Mylan Institutional
    Galway, Ireland

    MI:134:1C:R2

    Mylan.com

    Each mL contains: Magnesium
    Chloride Hexahydrate 200 mg,
    Sodium Chloride 9 mg, Benzyl
    Alcohol 1% as a preservative,
    Water for Injection q.s. pH adjusted
    with Hydrochloric Acid and/or
    Sodium Hydroxide.

    Total osmolarity equivalent to
    2.951 mOsm/mL.

    Contains 1.97 mEq of Mg++ and CI¯
    per mL.

    WARNING: DO NOT USE IF A
    PRECIPITATE IS PRESENT.

    Store at 20° to 25°C (68° to 77°F).
    [See USP Controlled Room
    Temperature.]

    Usual Dosage: See accompanying
    prescribing information.

    Magnesium Chloride Injection 200 mg/mL (20 percent w/v) Carton Label
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  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CHLORIDE 
    magnesium chloride injection
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67457-134
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 200 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE 9 mg  in 1 mL
    BENZYL ALCOHOL 10 mg  in 1 mL
    WATER  
    HYDROCHLORIC ACID  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67457-134-50 1 in 1 CARTON
    1 50 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 03/14/2013
    Labeler - Mylan Institutional LLC (790384502)
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