Label: HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION solution, concentrate

  • NDC Code(s): 81943-501-01
  • Packager: AQUA MEDICA, S.A. DE C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 19, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a Hemodialysis-Grade Sodium Bicarbonate Solution.

    This solution already diluted 1:27:57 with purified water (standard 13959:2014), provides:

    Sodium: 35.0 mEq/l

    Bicarbonate: 35.0 mEq/l

    Each 1000 mL of this solution contains:

    Sodium bicarbonate USP, hemodialysis grade: 84.0 g

    Purified water (standard ISO 13959:2014), csp: 1000 mL

  • Active Ingredient(s)

    Sodium Bicarbonate: Antiseptic

  • Purpose

    For use only with 3-pump hemodialysis machines.

  • Use

    Use oly with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standard ISO 13959:2014) IN A RATIO 1:1.23:32.77.

  • Warnings

    The solution should be transparent and colorless. Do not use if cloudy or with broken seal. If not all of the contents are used, discard the excess. Keep at room temperature.

  • DOSAGE & ADMINISTRATION

    For use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water.

  • Do not use

    • If cloudy or with broken seal.
  • WHEN USING

    If not all of the contents are used, discard the excess.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Other information

    • Keep at room temperature.
  • Inactive ingredients

    Purified water (standard ISO 13959:2014)

  • Package Label - Principal Display Panel

    3785 mL NDC: 81943-501-01 3785 mL Label

  • INGREDIENTS AND APPEARANCE
    HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION 
    hemodialysis grade sodium bicarbonate solution solution, concentrate
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-501
    Route of AdministrationHEMODIALYSIS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE8.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81943-501-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/30/2020
    Labeler - AQUA MEDICA, S.A. DE C.V. (816672224)
    Establishment
    NameAddressID/FEIBusiness Operations
    AQUA MEDICA, S.A. DE C.V.816672224manufacture(81943-501)