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  5. Label Information: Normal Salt

FDA Label for Normal Salt

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A PHYSICIAN BEFORE USE
    7. STOP USE AND ASK A PHYSICIAN
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. PRINCIPAL DISPLAY PANEL

Normal Salt Product Label

The following document was submitted to the FDA by the labeler of this product Graxcell Pharmaceutical, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

Principal Display Panel



NDC 70795-1120-1

GRAXCELL PHARMACEUTICAL, LLC.

Sodium Chloride Tablets, USP

Normal Salt Tablets

For solution or oral use

100 1 gm Tablets

Label - 1

Label - 1

NDC 70795-1120-0

GRAXCELL PHARMACEUTICAL, LLC.

Sodium Chloride Tablets, USP

Normal Salt Tablets

For solution or oral use

1000 1 gm Tablets


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