Drug Facts
Active Ingredient (in each tablet)
Sodium Chloride, USP 1 Gram
Sodium Chloride Tablet
FDA Label NDC 58657-119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product Sodium Chloride (NDC 58657-119). 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, inactive ingredients, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
NONE
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
Otc - Do Not Use
Do not use without consulting a physician
Otc - Ask Doctor
Ask a physician before use if you have a sodium restricted diet due to multiple organ diseases
Otc - Stop Use
Stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Keep Out Of Reach Of Chlidren
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- to make 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.
Other Information:
- each tablet contains: sodium 394 mg
- store at room temperature 15°C to 30°C (59°F to 86°F)
- Product does not contain any inactive ingredients
- Supplied as round white tablet imprinted with "M119"
Otc - Questions
Questions or comments?1-877-250-3427
Other
Rev. 09/25
Manufactured in the U.S.A. for
Method Pharmaceuticals, LLC
Southlake, Texas 76092
Package Label
NDC-58657-119-01
Sodium Chloride Tablets, USP
1 gram
Normal salt tablets
For solutins or oral use
100 tablets
Label (58657 119 01)
* Please review the disclaimer below.
