Label: SODIUM CHLORIDE 1 GRAM- sodium chloride tablet

  • NDC Code(s): 77333-835-10, 77333-835-25
  • Packager: Gendose Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • ACTIVE INGREDIENT (IN EACH TABLET)

    SODIUM CHLORIDE, USP 1 GRAM

  • PURPOSE

    ELECTROLYTE REPLENISHER

  • USES

    • FOR TTHE 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

    • 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 CONTIUE FOR MORE THAN 24 HOURS.
    • IF PREGNANT OR BREAST FEEDING, ASK A PHYSICIAN BEFORE USE.
  • KEEP OUT OF REACH OF CHILDREN

    • KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
  • DIRECTIONS

    • TO MAKE AN ISOTONIC SOLUTION OF SODIUM CHLORIDE, DISSOLVE 1 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.
  • INACTIVE INGREDIENTS

    NONE

  • OTHER INFORMATION

    • EACH TABLET CONTAINS: SODIUM 394 MG
    • STORE AT ROOM TEMPERATURE 15° - 30°C (59° - 86°F)
    • PRODUCT DOES NOT CONTAINS ANY INACTIVE INGREDIENTS.
  • PRINCIPAL DISPLAY PANEL

    01b LBL_Sodium Chloride

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE  1 GRAM
    sodium chloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77333-835
    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
    ShapeROUNDSize13mm
    FlavorImprint Code G13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77333-835-10100 in 1 BOX05/15/2020
    1NDC:77333-835-251 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01805/15/2020
    Labeler - Gendose Pharmaceuticals, LLC (080257510)
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