Sodium Chloride Tablets, USP

Manufacturer
Citragen Pharmaceuticals Inc
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:04

Label at a glance#

ProductSodium Chloride Normal Salt
Active ingredientSODIUM CHLORIDE
Label structure9 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 2 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 or two tablet orally as directed by your physician.

Storage and handling

each tablet contains: sodium 197 mg store at room temperature 15°-30°C (59°-86°F) product does not contain any inactive ingredients

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sodium Chloride, USP 500 mg

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

OTC - DO NOT USE SECTION

Do not use without consulting a physician

OTC - ASK DOCTOR SECTION

Ask a physician before use if you have a sodium restricted diet due to multiple organ diseases

OTC - STOP USE SECTION

Stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OVERDOSAGE 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 2 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 or two tablet orally as directed by your physician.

Other Information:

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 197 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • product does not contain any inactive ingredients

Questions or comments?

OTC - QUESTIONS SECTION

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. 07/20 R-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CitraGen Pharmaceuticals, Inc.

NDC: 70369‐010‐09

Sodium Chloride Tablets, USP 500 mg

Normal salt tablets

For solution or oral use

200 tablets

200 Count Bottle Label200 Count Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2387545sodium chloride 500 MG Oral TabletPSN3
2387545sodium chloride 500 MG Oral TabletSCD3
2387545NaCl 500 MG Oral TabletSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70369-010-092025-02-01C16284748780-12cef2736-7a92-d83d-e063-dadaa90ab31fSodium Chloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70369-010-09Sodium ChlorideNormal Salt200 in 1 BOTTLETABLET2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70369-010SODIUM CHLORIDE NORMAL SALT (SODIUM CHLORIDE) TABLET [CITRAGEN PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 1 package rows20250131_aae783b2-18fe-69ca-e053-2a95a90a0800.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70369-01070369-010-09

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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
Sodium Chloride Normal SaltSODIUM CHLORIDECitragen Pharmaceuticals Incaae783b2-18fe-69ca-e053-2a95a90a08002025-01-30WarningsExact identifier
ndc (package): 70369-010-09
ndc (product): 70369-010
ndc11 (package): 70369001009
spl id: 2ce80e1e-5259-596d-e063-6294a90add01
spl set id: aae783b2-18fe-69ca-e053-2a95a90a0800

Reported adverse events (FAERS/openFDA)#

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