SODIUM CHLORIDE NORMAL SALT- sodium chloride tablet

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC, ELYSIUM PHARMACEUTICALS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 physician ifsymptoms 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 (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

INACTIVE INGREDIENT

None

Questions?

call toll-free 1-800-630-8895

SPL UNCLASSIFIED SECTION

Manufactured for:

Advanced Rx LLC

1942 NE 163rd St.

North Miami Beach,

FL 33162 U.S.A.

Made in USA

PRINCIPAL DISPLAY PANEL

NDC: 80513-608-01

Sodium Chloride Tablets, USP 1 Gram

Normal Salt Tablets

For solution or oral use

100 Tablets

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE   NORMAL SALT
sodium chloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-608
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	1 g

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	HP1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-608-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/01/2025

Labeler - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		915664486	manufacture(80513-608)