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NDC 70795-1120-00 Normal Salt 1 g/1 Details

Normal Salt 1 g/1

Normal Salt is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by GRAXCELL PHARMACEUTICAL, LLC. The primary component is SODIUM CHLORIDE.

Product Information

NDC	70795-1120
Product ID	70795-1120_d3ae32a9-fefe-2f62-e053-2a95a90a94f8
Associated GPIs	79750010000320
GCN Sequence Number	060491
GCN Sequence Number Description	sodium chloride TABLET SOL 1000 MG MISCELL
HIC3	C1B
HIC3 Description	SODIUM/SALINE PREPARATIONS
GCN	26657
HICL Sequence Number	000538
HICL Sequence Number Description	SODIUM CHLORIDE
Brand/Generic	Generic
Proprietary Name	Normal Salt
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	1
Active Ingredient Units	g/1
Substance Name	SODIUM CHLORIDE
Labeler Name	GRAXCELL PHARMACEUTICAL, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70795-1120-00 (70795112000)

Pricing Information	N/A
NDC Package Code	70795-1120-0
Billing NDC	70795112000
Package	1000 TABLET in 1 BOTTLE (70795-1120-0)
Marketing Start Date	2017-10-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f3f09817-8a38-4aa1-956b-69d9cf695074 Details

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

Enter section text here

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

INACTIVE INGREDIENTS

NONE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NORMAL SALT

sodium chloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70795-1120
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
POWDERED CELLULOSE (UNII: SMD1X3XO9M)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	G13
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70795-1120-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
2	NDC:70795-1120-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
3	NDC:70795-1120-3	300 in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2020
4	NDC:70795-1120-4	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	10/02/2017

Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Name	Address	ID/FEI	Business Operations
Establishment
GRAXCELL PHARMACEUTICAL, LLC		056556923	manufacture(70795-1120)

Revised: 12/2021

Document Id: d3ae32a9-fefe-2f62-e053-2a95a90a94f8

Set id: f3f09817-8a38-4aa1-956b-69d9cf695074

Version: 6

Effective Time: 20211221