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| Product NDC Code | 83335-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Sodium chloride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 313009 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Wittman Pharma, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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 Normal Salt Tablets SODIUM CHLORIDE CHLORIDE ION SC
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.Drug Facts 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 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 Questions or comments? Call 1-352-549-9917 M-F 9am - 5pm EST Salt Label
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.
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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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