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Sodium chloride 1 gram - Medication Information

Product NDC Code 77333-844
Drug Name

Sodium chloride 1 gram

Type Brand
Active Ingredients
Sodium chloride 1 g/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 313009
Application Number part349
Labeler Name Gendose Pharmaceuticals, LLC
Packages
Package NDC Code Description
77333-844-10 100 blister pack in 1 box (77333-844-10) / 1 tablet in 1 blister pack (77333-844-25)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT (IN EACH TABLET) SODIUM CHLORIDE, USP 1.0 GRAM

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DIRECTIONS TO MAKE AN ISOTONIC SOLUTION OF SODIUM CHLORIDE, DISSOLVE 1 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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS NONE

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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.

Purpose

Information about the drug product’s indications for use.
PURPOSE ELECTROLYTE REPLENISHER

Spl product data elements

Usually a list of ingredients in a drug product.
SODIUM CHLORIDE 1 GRAM SODIUM CHLORIDE SODIUM CHLORIDE CHLORIDE ION S13

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
01b LBL_Sodium Chloride_77333-844-10

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Storage and handling

Information about safe storage and handling of the drug product.
OTHER INFORMATION EACH TABLET CONTAINS: SODIUM 394 MG STORE AT ROOM TEMPERATURE 15° - 30°C (59° - 86°F) PRODUCT DOES NOT CONTAINS ANY INACTIVE INGREDIENTS.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API