Normal Salt Tablet
FDA Label NDC 55681-305

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Normal Salt (NDC 55681-305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a physician before use, stop use and ask a physician, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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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

Inactive Ingredients

NONE

Package Label.Principal Display Panel

NDC 55681-305-02 - 200 Count

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