NORMAL SALT- sodium chloride tablet 
GRAXCELL PHARMACEUTICAL, LLC

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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Graxcell Pharmaceutical Sodium Chloride Tablets, USP; Normal Salt Tablets (1 gram)

Active ingredient (in each tablet)

Sodium Chloride, USP 1.0 gram

Purpose

Electrolyte Replenisher

Uses


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

Other information

INACTIVE INGREDIENTS

NONE

100

1000

300

NORMAL SALT 
sodium chloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE1 g
Inactive Ingredients
Ingredient NameStrength
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorImprint Code G13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70795-1120-1120 in 1 BOTTLE; Type 0: Not a Combination Product10/02/2017
2NDC:70795-1120-01000 in 1 BOTTLE; Type 0: Not a Combination Product10/02/2017
3NDC:70795-1120-3300 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
4NDC:70795-1120-4100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/02/2017
Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Revised: 11/2020
Document Id: aa32c555-73a7-4c7b-ac45-53d6d60e5843
Set id: f3f09817-8a38-4aa1-956b-69d9cf695074
Version: 5
Effective Time: 20201116
 
GRAXCELL PHARMACEUTICAL, LLC