Sodium Chloride Normal Salt Tablets (1 gram)

Manufacturer
Safrel Pharmaceuticals, LLC.
Effective date
2022-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:47:40

Label at a glance#

ProductNormal Salt
Active ingredientSODIUM CHLORIDE
Label structure8 sections

Indications and 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

Dosage and administration

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

Storage and handling

each tablet contains: sodium 394 mg store at room temperature 15°-30°C (59°-86°F) product does not contain any inactive ingredients

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride, USP 1.0 gram

Purpose

OTC - PURPOSE SECTION

Electrolyte Replenisher

Uses

INDICATIONS & USAGE SECTION


  • 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

WARNINGS SECTION

Enter section text here

Do not use

OTC - DO NOT USE SECTION

without consulting a physician

Ask a physician before use

OTC - ASK DOCTOR SECTION

 if you have a sodium restricted diet due to multiple organ diseases

Stop use and ask a physician

OTC - STOP USE SECTION

If symptoms of heat cramps continue for more than 24 hours

If pregnant or breast-feeding

PREGNANCY SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

NONE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sodiumsodiumNDC 71309-154-03 - 300 Count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313009sodium chloride 1 GM Oral TabletPSN1
313009sodium chloride 1000 MG Oral TabletSCD1
313009NaCl 1000 MG Oral TabletSY1
313009sodium chloride 0.124 MEQ/ML Oral SolutionSY1
313009sodium chloride 0.171 MEQ/ML Oral SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71309-154-032024-01-30C16284748780-11030e365-4806-111a-e063-dadaa90a10e2Sodium Chloride Normal Salt Tablets (1 gram)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-154-03Normal Salt300 in 1 BOTTLETABLET3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-154NORMAL SALT (SODIUM CHLORIDE) TABLET [SAFREL PHARMACEUTICALS, LLC.]1Legacy NDC, 1 package rows20220127_d6787875-3e0f-e506-e053-2a95a90a6eaa.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71309-15471309-154-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d6787875-3e10-e506-e053-2a95a90a6eaad6787875-3e0f-e506-e053-2a95a90a6eaa2022-01-21WarningsExact identifier
spl id: d6787875-3e10-e506-e053-2a95a90a6eaa
spl set id: d6787875-3e0f-e506-e053-2a95a90a6eaa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.