Label: SODIUM CHLORIDE NORMAL SALT- sodium chloride tablet

  • NDC Code(s): 58657-118-01
  • Packager: Method Pharmaceuticals
  • 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 October 16, 2021

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  • Uses

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

    Electrolyte Replenisher

  • Ask a physician

    before use if you have a sodium restricted diet due to multiple organ disease

  • Stop use

    and ask a physician if symptoms of heat cramps continue for more than 24 hours.

  • If pregnant or breastfeeding,

    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 isotonic solutions of sodium chloride, dissolve one tablet in 120 mL (four ounces) of distilled water and use as directed by a physician.
    • if used an electrolyte replinisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as directed by a physician.
  • Warnings

    Do not use without consulting a physician.

  • Active ingredients

    Sodium Chloride

  • Inactive Ingredient

    Product does not contain any inactive ingredients

  • Sodium Chloride

    label

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE  NORMAL SALT
    sodium chloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE1 g
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code M118
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-118-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/23/2021
    Labeler - Method Pharmaceuticals (060216698)