SODIUM CHLORIDE NORMAL SALT- sodium chloride tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Available from:
Citragen Pharmaceuticals Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Electrolyte Replenisher - 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
Authorization status:
OTC monograph final
Authorization number:
70369-007-02, 70369-007-03, 70369-007-07

SODIUM CHLORIDE NORMAL SALT- sodium chloride tablet

Citragen Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sodium Chloride Tablets, USP

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

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

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

CitraGen Pharmaceuticals, Inc.

NDC: 70369 007 03

Sodium Chloride Tablets, USP 1 gram

Normal salt tablets

For solution or oral use

100 Tablets

CitraGen Pharmaceuticals, Inc.

NDC: 70369 007 07

Sodium Chloride Tablets, USP 1 gram

Normal salt tablets

For solution or oral use

300 Tablets

SODIUM CHLORIDE NORMAL SALT

sodium chloride tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 36 9 -0 0 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Citragen Pharmaceuticals Inc

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

SODIUM CHLORIDE

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

12mm

Flavor

Imprint Code

CG0 0 7

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 36 9 -0 0 7-0 2

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/22/20 19

2

NDC:70 36 9 -0 0 7-0 3

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/22/20 19

3

NDC:70 36 9 -0 0 7-0 7

30 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 9 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

0 3/22/20 19

Labeler -

Citragen Pharmaceuticals Inc (024949457)

Registrant -

Citragen Pharmaceuticals Inc (024949457)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Citragen Pharmaceuticals Inc

0 249 49 457

ma nufa c ture (70 36 9 -0 0 7)

Revised: 3/2020

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