SODIUM CHLORIDE 1 GRAM- sodium chloride tablet

SODIUM CHLORIDE by

Drug Labeling and Warnings

SODIUM CHLORIDE by is a Otc medication manufactured, distributed, or labeled by Gendose Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 USE WITHOUT CONSULTING A PHYSICIAN.
• ASK A PHYSICIAN BEFORE USE IF YOU HAVE A SODIUM RESTRICTED DIET DUE TO MULTIPLE ORGAN DISEASES.
• STOP USE AND ASK A PHYSICIAN IF SYMPTOMS 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

• KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• TO MAKE AN ISOTONIC SOLUTION OF SODIUM CHLORIDE, DISSOLVE 1 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)
• PRODUCT DOES NOT CONTAINS ANY INACTIVE INGREDIENTS.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE   1 GRAM
sodium chloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77333-844
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	S13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77333-844-10	100 in 1 BOX	05/15/2020
1	NDC: 77333-844-25	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	05/15/2020

Labeler - Gendose Pharmaceuticals, LLC (080257510)

Registrant - Gendose Pharmaceuticals, LLC (080257510)

Establishment
Name	Address	ID/FEI	Business Operations
Neeyaan, LLC		118819217	manufacture(77333-844)