Drug Facts
Active ingredient (in each tablet)
Sodium Chloride, USP 1.0 Gram
Sodium Chloride Tablet
FDA Label NDC 80513-608
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Sodium Chloride (NDC 80513-608). 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, purpose, uses, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Do Not Use
Do not usewithout consulting a physician
Otc - Ask Doctor
Ask a physician before use if you havea sodium restricted diet due to multiple organ diseases
Otc - Stop Use
Stop use and ask a physician ifsymptoms 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 Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
- DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS MISSING OR DAMAGED
Questions?
call toll-free 1-800-630-8895
Other
Manufactured for:
Advanced Rx LLC
1942 NE 163rd St.
North Miami Beach,
FL 33162 U.S.A.
Made in USA
Package Label.Principal Display Panel
NDC 80513-608-01
Sodium Chloride Tablets, USP 1 Gram
Normal Salt Tablets
For solution or oral use
100 Tablets
Label (Label)
* Please review the disclaimer below.
