Sodium Chloride Tablet
FDA Label NDC 77333-846
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Sodium Chloride (NDC 77333-846). 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, 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
Do not usewithout consulting a physician
Ask a physician before use if you havea sodium restricted diet due to multiple organ diseases
Stop use and ask a physicianif symptoms of heat cramps continue for more than 24 hours
If pregnant or breast feeding,ask a health professional before use.
Otc - 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 (1-800-222-1222) immediately.
Directions
• to make an isotonic 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
Inactive Ingredients
None
Other Information
•
each tablet contains:sodium 394 mg
• store at room temperature 15° - 30°C (59° - 86°F)
• this product does not contains any inactive ingredients
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