Label: SODIUM CHLORIDE NORMAL SALT- sodium chloride tablet

  • NDC Code(s): 70369-007-02, 70369-007-03, 70369-007-07
  • Packager: Citragen Pharmaceuticals Inc
  • 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 March 9, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

    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.

    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
  • Questions or comments?

    Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: info@citragenpharma.com

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Manufactured by:

    CitraGen Pharmaceuticals, Inc.,
    Fremont, CA 94538.

    www.citragenpharma.com

    Rev. 02/19 R-00

  • PRINCIPAL DISPLAY PANEL

    CitraGen Pharmaceuticals, Inc.

    NDC: 70369‐007‐02

    Sodium Chloride Tablets, USP 1 gram

    Normal salt tablets

    For solution or oral use
    500 Tablets

    THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    500's Bottle Label

  • PRINCIPAL DISPLAY PANEL

    CitraGen Pharmaceuticals, Inc.

    NDC: 70369‐007‐03

    Sodium Chloride Tablets, USP 1 gram

    Normal salt tablets

    For solution or oral use
    100 Tablets

    100's Bottle Label

  • PRINCIPAL DISPLAY PANEL

    CitraGen Pharmaceuticals, Inc.

    NDC: 70369‐007‐07

    Sodium Chloride Tablets, USP 1 gram

    Normal salt tablets

    For solution or oral use
    300 Tablets

    300s Pack Label

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE  NORMAL SALT
    sodium chloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70369-007
    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 CG007
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70369-007-02500 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2019
    2NDC:70369-007-03100 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2019
    3NDC:70369-007-07300 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/22/2019
    Labeler - Citragen Pharmaceuticals Inc (024949457)
    Registrant - Citragen Pharmaceuticals Inc (024949457)
    Establishment
    NameAddressID/FEIBusiness Operations
    Citragen Pharmaceuticals Inc024949457manufacture(70369-007)