Label: NORMAL SALT- sodium chloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 21, 2021

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  • Active ingredient (in each tablet)

    Sodium Chloride, USP 1.0 gram

  • Purpose

    Electrolyte Replenisher

  • Uses


    • for the preparation of normal isotonic solution of Sodium chloride
    • as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration
    • any alternative use as directed by a physician
  • Warnings

    Enter section text here

    Do not use

    without consulting a physician

    Ask a physician before use

     if you have a sodium restricted diet due to multiple organ diseases

    Stop use and ask a physician

    If symptoms of heat cramps continue for more than 24 hours

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away

  • Directions

    • to make isontonic solution of sodium chloride, dissolve one tablet in 120 ml (four ounces) of distilled water and use as directed by a physician
    • if used as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as
      directed by your physician
  • Other information

    • each tablet contains: sodium 394 mg
    • store at room temperature 15°-30°C (59°-86°F)
    • product does not contain any inactive ingredients
  • INACTIVE INGREDIENTS

    NONE

  • PRINCIPAL DISPLAY PANEL

    100

    1000

    300

  • INGREDIENTS AND APPEARANCE
    NORMAL SALT 
    sodium chloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE1 g
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code G13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70795-1120-1120 in 1 BOTTLE; Type 0: Not a Combination Product10/02/2017
    2NDC:70795-1120-01000 in 1 BOTTLE; Type 0: Not a Combination Product10/02/2017
    3NDC:70795-1120-3300 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
    4NDC:70795-1120-4100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/02/2017
    Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)
    Establishment
    NameAddressID/FEIBusiness Operations
    GRAXCELL PHARMACEUTICAL, LLC056556923manufacture(70795-1120)
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