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 Citragen Pharmaceuticals Inc. 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 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.

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: info@citragenpharma.com

SPL UNCLASSIFIED SECTION

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

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

PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369‐007‐03

Sodium Chloride Tablets, USP 1 gram

Normal salt tablets

For solution or oral use
100 Tablets

PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369‐007‐07

Sodium Chloride Tablets, USP 1 gram

Normal salt tablets

For solution or oral use
300 Tablets

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE  NORMAL SALT
sodium chloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70369-007
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	12mm
Flavor		Imprint Code	CG007
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70369-007-02	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2019
2	NDC: 70369-007-03	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2019
3	NDC: 70369-007-07	300 in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/22/2019

Labeler - Citragen Pharmaceuticals Inc (024949457)

Registrant - Citragen Pharmaceuticals Inc (024949457)

Establishment
Name	Address	ID/FEI	Business Operations
Citragen Pharmaceuticals Inc		024949457	manufacture(70369-007)