Label: SODIUM CHLORIDE 1 GRAM- sodium chloride tablet

  • NDC Code(s): 77333-844-10, 77333-844-25
  • Packager: Gendose Pharmaceuticals, LLC
  • 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 June 28, 2023

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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

    • 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

    • 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_77333-844-10

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE  1 GRAM
    sodium chloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77333-844
    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 S13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77333-844-10100 in 1 BOX05/15/2020
    1NDC:77333-844-251 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34905/15/2020
    Labeler - Gendose Pharmaceuticals, LLC (080257510)
    Registrant - Gendose Pharmaceuticals, LLC (080257510)
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