Drug Facts
Active ingredient (in each tablet)
Sodium Chloride, USP 1.0 gram
Sodium Chloride Tablet
FDA Label NDC 70369-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Citragen Pharmaceuticals Inc for the product Sodium Chloride (NDC 70369-007). 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, overdosage, 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 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.
Overdosage
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
Questions Or Comments?
Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: [email protected]
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by:
CitraGen Pharmaceuticals, Inc.,
Fremont, CA 94538.
www.citragenpharma.com
Rev. 02/19 R-00
Package Label.Principal Display Panel
CitraGen Pharmaceuticals, Inc.
NDC: 70369‐007‐02
Sodium Chloride Tablets, USP 1 gram
Normal salt tablets
For solution or oral use
500 Tablets
THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
500's Bottle Label (Cg007 Ndc 70369 007 02)
CitraGen Pharmaceuticals, Inc.
NDC: 70369‐007‐03
Sodium Chloride Tablets, USP 1 gram
Normal salt tablets
For solution or oral use
100 Tablets
100's Bottle Label (Cg007 Ndc 70369 007 03)
CitraGen Pharmaceuticals, Inc.
NDC: 70369‐007‐07
Sodium Chloride Tablets, USP 1 gram
Normal salt tablets
For solution or oral use
300 Tablets
300s Pack Label (Cg007 300s R00 Ndc 70369 007 07)
* Please review the disclaimer below.
