Label: SODIUM CHLORIDE solution, concentrate

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated December 9, 2021

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  • Statement of Identity

    Safecor Health, LLC
    4060 Business Park Drive
    Columbus, OH 43204 USA

    SODIUM CHLORIDE

    23.4% (234 mg/ml)
    (4 mEq per ml)
    CONCENTRATED
    ORAL SOLUTION

  • FOR INSTITUTIONAL USE ONLYUSE ONLY AS DIRECTED BY A PHYSICIAN

    The dosage of Sodium Chloride Oral Solution 23.4% is predicated on the specific requirements of the patient based on clinical and laboratory information.

     Ages 9 to 50 4 ml (equivalent to 936 mg)
     Children under 9 years and adults over 50 years Consult a physician

    Supplement Facts
    SERVING SIZE: 4 ml (equivalent to 936 mg of Sodium Chloride)
    SERVINGS PER CONTAINER: About 118

    Amount Per Serving% of Daily Value*
    Sodium 36825%

    (From Sodium Chloride 23.4% (4 mEq/ml))
    *Percent daily value is based on a 2,000 calorie diet
    Inactive Ingredients: Purified water

  • WARNING:

    Use only as directed by a physician.

    BULK CONTAINER
    NOT FOR HOUSEHOLD USE

    TAMPER EVIDENT:
    Do not use if seal under cap is torn, broken, or missing

    Discard Opened Product After 90 Days

  • PRINCIPAL DISPLAY PANEL - 473 ml (1 Pint) Bottle

    FOR INSTITUTIONAL USE ONLY
    USE ONLY AS DIRECTED BY A PHYSICIAN
    The dosage of Sodium Chloride Oral Solution 23.4% is predicated on the specific requirements of the patient based on clinical and laboratory information.

     Ages 9 to 50 4 ml (equivalent to 936 mg)
     Children under 9 years and adults over 50 years Consult a physician

    Store at room temperature 20°C-25°C (68°F-77°F)

    WARNING: Use only as directed by a physician.

    BULK CONTAINER
    NOT FOR HOUSEHOLD USE

    TAMPER EVIDENT:
    Do not use if seal under cap is torn, broken, or missing

    Discard Opened Product After 90 Days

    Lot. #
    Exp.Date

    SAFECOR
    HEALTH
    48433-215-01

    SODIUM
    CHLORIDE
    23.4% (234 mg/ml)
    (4 mEq per ml)
    CONCENTRATED
    ORAL SOLUTION
    473 ml (1 Pint)

    Supplement Facts
    SERVING SIZE: 4 ml (equivalent to 936 mg of Sodium Chloride)
    SERVINGS PER CONTAINER: About 118

     Amount Per Serving % of Daily Value*
     Sodium           368 mg 25%

    (From Sodium Chloride 23.4% (4 mEq/ml))
    *Percent daily value is based on a 2,000 calorie diet

    Inactive Ingredients: Purified water

    Manufactured for:
    Safecor Health, LLC
    4060 Business Park Drive
    Columbus, OH 43204 USA
    Questions or comments call 1-800-447-1006

    PN5716
    04/2021
    Code#: L-158
    3 48433 21501 2

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride solution, concentrate
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:48433-215
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE936 mg  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:48433-215-01473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement12/20/2021
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Llorens Pharmaceutical International Division, Inc.037342305MANUFACTURE(48433-215)